New research published today on bmj suggests there is no strong evidence that the popular smoking cessation drug varenicline increases the risk of self harm or depression compared to other cessation products.
The newly introduced Varenicline is a smoking cessation product of proven effectiveness. However, there have been concerns that it may increase the risk of suicidal behavior and suicide. Varenicline continues to be used widely, despite warnings about the probable increased risks issued by regulatory authorities worldwide.
A team of researchers from the University of Bristol and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) set out to provide further verification. They compared the risk of self harm among people taking varenicline with the risk of self harm associated with other smoking cessation products, such as bupropion and nicotine replacement therapy (patch, inhaler, gum, tablet or lozenge).
The researchers used data from the General Practice Research Database, including 80,660 men and women aged between 18 and 95 years. They were all prescribed a new course of smoking cessation product between September 2006 and May 2008.
Participants were prescribed nicotine replacement products (63,265), varenicline (10,973), or bupropion (6,422).
There was a review of all electronic patient records over the period of the prescription and for three months after the date of the last prescription. Incidences of fatal and non-fatal self-harm, suicidal thoughts and depression were examined.
Findings indicated there was no clear evidence of an increased risk of self harm, suicidal thoughts or depression associated with either varenicline or bupropion. Confounding factors were taken into account.
Although they found no strong evidence of an increased risk of self harm related to varenicline, the authors caution "the limited power of the study means we cannot rule out either a halving or a twofold increased risk."
They recommend further investigation of varenicline's effect on suicide risk in other databases and secondary analysis of all adverse events reporting in clinical trials.
In closing, they caution that any risks must be weighed against the long term health benefits of stopping smoking and the effectiveness of varenicline as a smoking cessation product.
"Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database"
D Gunnell, professor of epidemiology, D Irvine, pharmacoepidemiologist, L Wise, senior pharmacoepidemiologist, C Davies, senior pharmacovigilance assessor, R M Martin, professor of clinical epidemiology
BMJ 2009; 339:b3805
doi:10.1136/bmj.b3805
bmj
Written by Stephanie Brunner (B.A.)
воскресенье, 31 июля 2011 г.
пятница, 29 июля 2011 г.
Michael Jellinek, M.D. Receives AACAP Irving Philips Award For Prevention
The American Academy of Child and Adolescent Psychiatry (AACAP), is pleased to announce that Michael Jellinek, M.D., is the recipient of the AACAP Irving Philips Award for Prevention. The annual award is given to a child and adolescent psychiatrist who has made significant contributions to the field of prevention of mental illnesses in children and adolescents.
Dr. Jellinek was instrumental in the creation of the Pediatric Symptom Checklist (PSC), a psychosocial screen designed to facilitate the recognition of cognitive, emotional, and behavioral problems in children and adolescents so that appropriate interventions can be begun as early as possible.
Dr. Jellinek's first work on the checklist was an effort to create a questionnaire that could identify children who would likely benefit from child psychiatric consultation. His collaboration with J. Michael Murphy, Ed.D., prompted the design of an outpatient screening tool that helps primary care physicians to determine which children need extra attention for psychosocial needs.
"We started designing an outpatient screening tool that would allow a primary care pediatrician to determine which children needed extra attention to their psychosocial needs. The PSC was validated against psychosocial dysfunction, not specific diagnoses, to be congruent with the pediatrician's view of development and their responsibility to provide comprehensive care," said Dr. Jellinek in a written statement.
Currently the PSC is accepted as a primary care screening approach to meet Medicaid Early Periodic Screening, Diagnosis, and Treatment (EPSDT) requirements. It is used by many primary care offices and community clinics, and is being rolled out as a national mandated psychosocial screening tool for children entering first grade in Chile. The PSC is free and available on the Internet.
Dr. Jellinek will present, "The Development, Implementation, and Potential Medical and Educational Uses of the Pediatric Symptom Checklist" at Honors Presentation 5 on Thursday, October 30th at the American Academy of Child and Adolescent Psychiatry Annual Meeting at the Sheraton Chicago Hotel and Towers.
Representing over 7,500 child and adolescent psychiatrists nationwide, the American Academy of Child and Adolescent Psychiatry (AACAP) is the leading authority on children's mental health. AACAP members actively research, diagnose, and treat psychiatric disorders affecting children, adolescents, and their families.
American Academy of Child and Adolescent Psychiatry
Dr. Jellinek was instrumental in the creation of the Pediatric Symptom Checklist (PSC), a psychosocial screen designed to facilitate the recognition of cognitive, emotional, and behavioral problems in children and adolescents so that appropriate interventions can be begun as early as possible.
Dr. Jellinek's first work on the checklist was an effort to create a questionnaire that could identify children who would likely benefit from child psychiatric consultation. His collaboration with J. Michael Murphy, Ed.D., prompted the design of an outpatient screening tool that helps primary care physicians to determine which children need extra attention for psychosocial needs.
"We started designing an outpatient screening tool that would allow a primary care pediatrician to determine which children needed extra attention to their psychosocial needs. The PSC was validated against psychosocial dysfunction, not specific diagnoses, to be congruent with the pediatrician's view of development and their responsibility to provide comprehensive care," said Dr. Jellinek in a written statement.
Currently the PSC is accepted as a primary care screening approach to meet Medicaid Early Periodic Screening, Diagnosis, and Treatment (EPSDT) requirements. It is used by many primary care offices and community clinics, and is being rolled out as a national mandated psychosocial screening tool for children entering first grade in Chile. The PSC is free and available on the Internet.
Dr. Jellinek will present, "The Development, Implementation, and Potential Medical and Educational Uses of the Pediatric Symptom Checklist" at Honors Presentation 5 on Thursday, October 30th at the American Academy of Child and Adolescent Psychiatry Annual Meeting at the Sheraton Chicago Hotel and Towers.
Representing over 7,500 child and adolescent psychiatrists nationwide, the American Academy of Child and Adolescent Psychiatry (AACAP) is the leading authority on children's mental health. AACAP members actively research, diagnose, and treat psychiatric disorders affecting children, adolescents, and their families.
American Academy of Child and Adolescent Psychiatry
среда, 27 июля 2011 г.
Scientific Link Between Acne Treatment And Depression Established By Researchers, UK
A drug commonly used to treat severe acne can lead to depressive behaviour in mice, according to research published in the journal Neuropsychopharmacology.
Since the drug's introduction in the early 1980s there have been controversial reports of depression and suicidal behaviour that may have occurred in some people taking Roaccutane.
This has led to the drug's manufacturers, Roche, including a warning in the product information that taking the medication may cause depression, psychosis and suicidal behaviour.
However, the chemical mechanism by which this might happen has never been established.
In new independent research, scientists at the universities of Bath and Texas at Austin gave Roaccutane to mice over a period of six weeks, and then monitored the rodents' behaviour.
They found that whilst there was no change in the physical abilities of the mice, the rodents spent significantly more time immobile in a range of laboratory assessments designed to test their stress responsiveness - suggesting that administration of Roaccutane increases depression-related behaviour in mice.
"Without more research it is difficult to say for sure whether the same link applies to people taking the drug," said Dr Sarah Bailey from the Department of Pharmacy and Pharmacology at the University of Bath.
"However, establishing a link between the active molecules within the drug and a change in depression-related behaviour, albeit in mice, is an important step forward in our understanding of the effects of this drug in the wider context of brain function.
"To date the only evidence for any link with patients has come from individual case reports and such patient data is complicated by the psychosocial effects of having severe acne.
"This laboratory evidence provides a useful model for future research into Roaccutane and understanding how this family of compounds affects the brain."
Roaccutane belongs to a group of medicines called retinoids - vitamin A-related compounds known to affect development of the nervous system. For this reason Roaccutane is not prescribed to pregnant women.
"Previously scientists thought that retinoids were only important in the development of the nervous system. Now there is a growing interest in retinoids as regulators of different aspects of brain function in adults," said Dr Bailey.
"While our research is the first to demonstrate that retinoids are capable of influencing depression-related behaviours, these compounds may also play a role in the pathology of Alzheimer's disease and schizophrenia".
This research was conducted through a collaboration between Dr. Sarah Bailey (Department of Pharmacy and Pharmacology, University of Bath) and Dr. Michelle Lane (Department of Human Ecology, Division of Nutritional Sciences, at the University of Texas at Austin) and funded by the University of Texas at Austin.
Notes
Kally C O'Reilly, Jason Shumake, F Gonzalez-Lima, Michelle A Lane and Sarah J Bailey (2006). 'Chronic Administration of 13-Cis-Retinoic Acid Increases Depression-Related Behavior in Mice'. Neuropsychopharmacology, Volume 31, Issue 9 (September 2006): 1919-1927
Lane, MA, Bailey SJ. (2005). 'Role of retinoid signalling in the adult nervous system'. Progress in Neurobiology, 75(4):275-93. This is a review article which gives lots of background.
The University of Bath is one of the UK's leading universities, with an international reputation for quality research and teaching. In 20 subject areas the University of Bath is rated in the top ten in the country.
Contact: Andrew McLaughlin
University of Bath
Since the drug's introduction in the early 1980s there have been controversial reports of depression and suicidal behaviour that may have occurred in some people taking Roaccutane.
This has led to the drug's manufacturers, Roche, including a warning in the product information that taking the medication may cause depression, psychosis and suicidal behaviour.
However, the chemical mechanism by which this might happen has never been established.
In new independent research, scientists at the universities of Bath and Texas at Austin gave Roaccutane to mice over a period of six weeks, and then monitored the rodents' behaviour.
They found that whilst there was no change in the physical abilities of the mice, the rodents spent significantly more time immobile in a range of laboratory assessments designed to test their stress responsiveness - suggesting that administration of Roaccutane increases depression-related behaviour in mice.
"Without more research it is difficult to say for sure whether the same link applies to people taking the drug," said Dr Sarah Bailey from the Department of Pharmacy and Pharmacology at the University of Bath.
"However, establishing a link between the active molecules within the drug and a change in depression-related behaviour, albeit in mice, is an important step forward in our understanding of the effects of this drug in the wider context of brain function.
"To date the only evidence for any link with patients has come from individual case reports and such patient data is complicated by the psychosocial effects of having severe acne.
"This laboratory evidence provides a useful model for future research into Roaccutane and understanding how this family of compounds affects the brain."
Roaccutane belongs to a group of medicines called retinoids - vitamin A-related compounds known to affect development of the nervous system. For this reason Roaccutane is not prescribed to pregnant women.
"Previously scientists thought that retinoids were only important in the development of the nervous system. Now there is a growing interest in retinoids as regulators of different aspects of brain function in adults," said Dr Bailey.
"While our research is the first to demonstrate that retinoids are capable of influencing depression-related behaviours, these compounds may also play a role in the pathology of Alzheimer's disease and schizophrenia".
This research was conducted through a collaboration between Dr. Sarah Bailey (Department of Pharmacy and Pharmacology, University of Bath) and Dr. Michelle Lane (Department of Human Ecology, Division of Nutritional Sciences, at the University of Texas at Austin) and funded by the University of Texas at Austin.
Notes
Kally C O'Reilly, Jason Shumake, F Gonzalez-Lima, Michelle A Lane and Sarah J Bailey (2006). 'Chronic Administration of 13-Cis-Retinoic Acid Increases Depression-Related Behavior in Mice'. Neuropsychopharmacology, Volume 31, Issue 9 (September 2006): 1919-1927
Lane, MA, Bailey SJ. (2005). 'Role of retinoid signalling in the adult nervous system'. Progress in Neurobiology, 75(4):275-93. This is a review article which gives lots of background.
The University of Bath is one of the UK's leading universities, with an international reputation for quality research and teaching. In 20 subject areas the University of Bath is rated in the top ten in the country.
Contact: Andrew McLaughlin
University of Bath
понедельник, 25 июля 2011 г.
Abortion Does Not Cause Depression Or Low Self-Esteem In Adolescents, National Study Finds
A new study has determined that teenagers who have abortions are no more likely to become depressed or have low self-esteem than their peers whose pregnancies do not end in abortion.
The study conducted by researchers from Oregon State University and University of California, San Francisco, is the first to use both depression and low self-esteem as outcomes with a nationally representative sample of adolescents.
The researchers found that young women in the study who had an abortion were no more likely to become depressed or have low self-esteem within the first year of pregnancy - or five years later - than their peers who were pregnant, but did not have an abortion.
The researchers used data from 289 respondents to the National Longitudinal Study of Adolescent Health (Add Health). Data were taken from three survey waves, starting in 1994-1995, surveyed again one year later, and then five years after that. The study is available online and will appear in the December issue of Perspectives on Sexual and Reproductive Health.
Lead author Jocelyn Warren, a post-doctoral research associate at OSU, said the study was intended to fill a major gap in abortion research.
"We know most teen pregnancies are not wanted pregnancies and an unwanted pregnancy can be very stressful," Warren said.
She said previous research has shown that adolescent girls who get pregnant report more depression and lower self-esteem compared to those who don't. "What we didn't know was whether psychological outcomes are worse for girls who choose abortion. This study says, 'No.'"
Warren noted that a 2008 report by the American Psychological Association found no evidence that an induced abortion causes mental health problems in adult women. Because of a scarcity of evidence, no conclusions were drawn at that time about adolescents. Warren said the results of their study with teen girls were consistent with the results of studies with adult women reviewed in the APA report.
"Abortion is a very controversial issue and a hot political one, obviously," said Marie Harvey, a professor of public health at OSU and a leading national researcher in the area of women's health. Harvey was Warren's doctoral adviser and is co-author of the paper.
"In the interest of women's health, it's critical that we conduct the most rigorous studies possible and use evidence-based information to inform public policy," Harvey said. "This is our goal in public health research but it may be even more important in areas such as abortion that are highly politicized."
According to the Guttmacher Institute, a nonprofit organization that monitors state abortion policies, 34 states require parental involvement in adolescents' abortion decisions. In addition, laws in seven states mandate that women be advised only of negative psychological consequences of abortion, including "post-abortion traumatic stress syndrome," a disorder that is not recognized by the American Psychological Association or the American Psychiatric Association.
Warren said it's important to note that individual women may have very different emotional responses to abortion. "But, on average, abortion does not appear to have major psychological consequences - for adult women or for teens."
"We have policies being made that are not evidence-based, and that have adverse consequences for women's health," Harvey said. "I cannot think of any other type of health practice where a doctor is forced by law to tell a patient about negative consequences that have not been proven or validated."
Harvey said their study had several strengths. For one thing, the data were from a national sample and are representative of adolescents who were in grades 7 through 12. Also, the study used standard measures of depression and self-esteem. Finally, the longitudinal data examined psychological symptoms before, during, and years after pregnancy, Harvey said.
The study conducted by researchers from Oregon State University and University of California, San Francisco, is the first to use both depression and low self-esteem as outcomes with a nationally representative sample of adolescents.
The researchers found that young women in the study who had an abortion were no more likely to become depressed or have low self-esteem within the first year of pregnancy - or five years later - than their peers who were pregnant, but did not have an abortion.
The researchers used data from 289 respondents to the National Longitudinal Study of Adolescent Health (Add Health). Data were taken from three survey waves, starting in 1994-1995, surveyed again one year later, and then five years after that. The study is available online and will appear in the December issue of Perspectives on Sexual and Reproductive Health.
Lead author Jocelyn Warren, a post-doctoral research associate at OSU, said the study was intended to fill a major gap in abortion research.
"We know most teen pregnancies are not wanted pregnancies and an unwanted pregnancy can be very stressful," Warren said.
She said previous research has shown that adolescent girls who get pregnant report more depression and lower self-esteem compared to those who don't. "What we didn't know was whether psychological outcomes are worse for girls who choose abortion. This study says, 'No.'"
Warren noted that a 2008 report by the American Psychological Association found no evidence that an induced abortion causes mental health problems in adult women. Because of a scarcity of evidence, no conclusions were drawn at that time about adolescents. Warren said the results of their study with teen girls were consistent with the results of studies with adult women reviewed in the APA report.
"Abortion is a very controversial issue and a hot political one, obviously," said Marie Harvey, a professor of public health at OSU and a leading national researcher in the area of women's health. Harvey was Warren's doctoral adviser and is co-author of the paper.
"In the interest of women's health, it's critical that we conduct the most rigorous studies possible and use evidence-based information to inform public policy," Harvey said. "This is our goal in public health research but it may be even more important in areas such as abortion that are highly politicized."
According to the Guttmacher Institute, a nonprofit organization that monitors state abortion policies, 34 states require parental involvement in adolescents' abortion decisions. In addition, laws in seven states mandate that women be advised only of negative psychological consequences of abortion, including "post-abortion traumatic stress syndrome," a disorder that is not recognized by the American Psychological Association or the American Psychiatric Association.
Warren said it's important to note that individual women may have very different emotional responses to abortion. "But, on average, abortion does not appear to have major psychological consequences - for adult women or for teens."
"We have policies being made that are not evidence-based, and that have adverse consequences for women's health," Harvey said. "I cannot think of any other type of health practice where a doctor is forced by law to tell a patient about negative consequences that have not been proven or validated."
Harvey said their study had several strengths. For one thing, the data were from a national sample and are representative of adolescents who were in grades 7 through 12. Also, the study used standard measures of depression and self-esteem. Finally, the longitudinal data examined psychological symptoms before, during, and years after pregnancy, Harvey said.
суббота, 23 июля 2011 г.
Novel Antidepressant Valdoxan(R), Receives EMEA CHMP Positive Opinion For Major Depressive Episodes
Valdoxan® today received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for its use in the treatment of adult patients with Major Depressive Episodes (MDE).1
Valdoxan is an innovative approach to the treatment of MDE and has demonstrated convincing efficacy in depressed patients with moderate-severe depression2, offering new hope to many of the more than 2.9 million people in the UK who are diagnosed as having depression at any one time.3
Data from its clinical development programme show that Valdoxan is effective against the core symptoms of depression, including depressed mood, anxiety, psychomotor retardation, sleep disturbances, and daytime fatigue.4-8
Valdoxan, the result of an advanced pharmacological research programme involving investigation centres all around the world, is a different approach to the treatment of depression that goes a step beyond the monoamine hypothesis. Valdoxan is an MT1 & MT2 melatonergic receptor agonist with 5-HT2C receptor antagonist properties.9,10 As a result of this novel mode of action, Valdoxan has demonstrated convincing antidepressant efficacy in addition to circadian rhythm resynchronisation.11 This mechanism of action is unlike those of commonly prescribed antidepressants such as selective serotonin reuptake inhibitors (SSRIs), and serotonin and noradrenaline reuptake inhibitors (SNRIs), since Valdoxan has no impact on serotonin levels.1
In clinical trials Valdoxan has demonstrated efficacy at a once-daily dose of 25 - 50 mg in moderately and severely depressed adult patients (18-65 years old) presenting with a first or recurrent episode of Major Depressive Disorder (MDD). 2, 4 - 8, 10
Short-term and long-term results from the extensive international development programme, including nearly 4,000 adult patients with MDD, were presented to the CHMP. This programme supported the antidepressant efficacy of Valdoxan as compared with placebo, SSRI and SNRI treatments. This programme also showed that Valdoxan's antidepressant efficacy was combined with a favourable tolerability profile. Indeed, most patients treated with Valdoxan did not present with any symptoms of sexual dysfunction.7 Furthermore, in double-blind placebo controlled trials patients treated with Valdoxan exhibited a body weight variation profile similar to that of placebo.13 Finally, studies indicate that Valdoxan has beneficial effects on disturbed sleep patterns in depression as early as the first week of treatment4 and is not associated with discontinuation symptoms upon cessation of treatment.14 As a precautionary measure liver function tests will be required during treatment with Valdoxan. In clinical trials an increase in serum transaminases (an indicator of liver function) was observed in some patients. When Valdoxan was discontinued in these patients, the serum transaminases usually returned to normal levels. Incidences of liver damage or pathology were rarely reported. 15
Valdoxan® was discovered and developed by Servier, France's leading independent pharmaceutical company. Subject to approval by the European Commission it will be marketed by Servier in the UK in 2009.
Key facts about Depression in the UK
- Depression is characterised by a low mood and loss of interest, usually accompanied by one or more of the following . low energy, change in appetite, weight or sleep pattern, poor concentration, feelings of guilt or worthlessness and suicidal ideas.16
- At least one person in every six becomes depressed in the course of their lives. One in twenty is clinically depressed.17
- Major depressive disorder is increasingly seen as chronic and relapsing, resulting in high levels of personal disability, lost quality of life for patients, their family and carers, multiple morbidity, suicide, higher levels of service use and many associated economic costs.18
- In 2000, 109.7 million lost working days were attributable to depression. 18
- The total annual cost of adult depression in England has been estimated at over ??9 million, of which ??370 million represents direct treatment costs.18
- Depression is currently the fourth leading cause of disability and disease worldwide. The World Health Organisation estimates that by the year 2020, major depression will be second only to chronic heart disease as an international health burden (this is measured by its cause of death, disability, incapacity to work and the medical resources it uses).19
- An estimated 15% of all depressed patients eventually kill themselves.20 Depression accounted for 2,615 deaths in the UK in 2000 alone21, which is roughly seven people a day.
About Servier
- Servier Laboratories Ltd is the UK subsidiary of the Servier Research Group, the leading independent French research based pharmaceutical company established in 1954 by Dr Jacques Servier.
- Established in 140 countries, The Servier Research Group has annual sales worldwide of over 3.5 billion euros.
- The key franchises of the Servier Research Group are Cardiovascular disease, Diabetes, Rheumatology, Central Nervous System and Oncology.
- Servier is a research based company which seeks to fulfil unmet patient need.
- Servier earmarks 25% of its turnover for research and development every year, which is considerably higher than the industry average.
- Foundation status provides Servier with the opportunity to focus on the development of innovative drugs.
servier.co.uk
References
1. EMEA website emea.europa.eu/pdfs/human/opinion/Valdoxan_57541108en.pdf (Date Last Accessed: 21 November 2008)
2. Montgomery SA and Kasper S. Int Clin Psychopharmacol. 2007; 22: 283-291
3. Ohayon MM, Priest RG, Guilleminault C, et al. Biol Psychiatry. 1999; 45: 300-307
4. Lemoine P, Guilleminault C and Alvarez E. J Clin Psychiatry. 2007; 68: 1723-1732
5. Oli?© JP and Kasper S. Int J Neuropsychopharmacol. 2007; 10: 661-673
6. Kennedy SH and Emsley R. Eur Neuropsychopharmacol. 2006; 16(2): 93-100
7. Kennedy SH, Rizvi S, Fulton K and Rasmussen J. J Clin Psychopharmacol. 2008; 28: 329-333
8. Kasper S, Laigle L and Bayl?© F. Eur Neuropsychopharmacol. 2008; 18(suppl4): S336. Abstract P2c022.
9. Chilman-Blair K, et al. Drugs of the Future. 2003; 28(1): 7-13
10. L??o H, Hale A and D'haenen H. Int Clin Psychopharmacol. 2002; 17: 239-247
11. Leproult R, Van Ondergergen A, L'Hermite-Bal?©riaux M, et al. Clin Endocrinol. 2005; 63: 298-304
12. Stahl S. Int Journal of Psychopharmacol. 2007; 10: 575-578
13. Data on File 07VADOF126
14. Montgomery Kennedy SH, Burrows GD, et al. Int Clin Psychopharmacol. 2004; 19: 271-280.
15. Data on File 08VAL0094
16. NICE depression guideline, Questions and Answers Depression and Anxiety nice.uk/nicemedia/pdf/CG022%20and%20CG023_QandA.pdf
(Date Last Accessed: 20 November 2008)
17. Mind Information Booklet: Understanding Depression.
mind.uk/Information/Bookletes/Understanding/Understanding+depression.htm
(Date Last Accessed: 20 November 2008)
18. Quality and Outcomes Framework, Revisions to the GMS Contract 2006-7
bma.uk/ap.nsf/Content/revisionnGMSFeb20062
(Date Last Accessed: 20 November 2008)
19. Moussavi S, Chatterji S, Verdes E, et al. Lancet. 2007; 370: 851??????"858
20. Scott J. British Medical Journal. .2006; 332: 985-986
21. Thomas C and Morris S. British Journal of Psychiatry. 2003; 183: 514-519.
Source
Katie Silverwood
Reynolds-MacKenzie
130 Shaftesbury Avenue
London W1D 5EU
reynoldsmackenzie
Valdoxan is an innovative approach to the treatment of MDE and has demonstrated convincing efficacy in depressed patients with moderate-severe depression2, offering new hope to many of the more than 2.9 million people in the UK who are diagnosed as having depression at any one time.3
Data from its clinical development programme show that Valdoxan is effective against the core symptoms of depression, including depressed mood, anxiety, psychomotor retardation, sleep disturbances, and daytime fatigue.4-8
Valdoxan, the result of an advanced pharmacological research programme involving investigation centres all around the world, is a different approach to the treatment of depression that goes a step beyond the monoamine hypothesis. Valdoxan is an MT1 & MT2 melatonergic receptor agonist with 5-HT2C receptor antagonist properties.9,10 As a result of this novel mode of action, Valdoxan has demonstrated convincing antidepressant efficacy in addition to circadian rhythm resynchronisation.11 This mechanism of action is unlike those of commonly prescribed antidepressants such as selective serotonin reuptake inhibitors (SSRIs), and serotonin and noradrenaline reuptake inhibitors (SNRIs), since Valdoxan has no impact on serotonin levels.1
In clinical trials Valdoxan has demonstrated efficacy at a once-daily dose of 25 - 50 mg in moderately and severely depressed adult patients (18-65 years old) presenting with a first or recurrent episode of Major Depressive Disorder (MDD). 2, 4 - 8, 10
Short-term and long-term results from the extensive international development programme, including nearly 4,000 adult patients with MDD, were presented to the CHMP. This programme supported the antidepressant efficacy of Valdoxan as compared with placebo, SSRI and SNRI treatments. This programme also showed that Valdoxan's antidepressant efficacy was combined with a favourable tolerability profile. Indeed, most patients treated with Valdoxan did not present with any symptoms of sexual dysfunction.7 Furthermore, in double-blind placebo controlled trials patients treated with Valdoxan exhibited a body weight variation profile similar to that of placebo.13 Finally, studies indicate that Valdoxan has beneficial effects on disturbed sleep patterns in depression as early as the first week of treatment4 and is not associated with discontinuation symptoms upon cessation of treatment.14 As a precautionary measure liver function tests will be required during treatment with Valdoxan. In clinical trials an increase in serum transaminases (an indicator of liver function) was observed in some patients. When Valdoxan was discontinued in these patients, the serum transaminases usually returned to normal levels. Incidences of liver damage or pathology were rarely reported. 15
Valdoxan® was discovered and developed by Servier, France's leading independent pharmaceutical company. Subject to approval by the European Commission it will be marketed by Servier in the UK in 2009.
Key facts about Depression in the UK
- Depression is characterised by a low mood and loss of interest, usually accompanied by one or more of the following . low energy, change in appetite, weight or sleep pattern, poor concentration, feelings of guilt or worthlessness and suicidal ideas.16
- At least one person in every six becomes depressed in the course of their lives. One in twenty is clinically depressed.17
- Major depressive disorder is increasingly seen as chronic and relapsing, resulting in high levels of personal disability, lost quality of life for patients, their family and carers, multiple morbidity, suicide, higher levels of service use and many associated economic costs.18
- In 2000, 109.7 million lost working days were attributable to depression. 18
- The total annual cost of adult depression in England has been estimated at over ??9 million, of which ??370 million represents direct treatment costs.18
- Depression is currently the fourth leading cause of disability and disease worldwide. The World Health Organisation estimates that by the year 2020, major depression will be second only to chronic heart disease as an international health burden (this is measured by its cause of death, disability, incapacity to work and the medical resources it uses).19
- An estimated 15% of all depressed patients eventually kill themselves.20 Depression accounted for 2,615 deaths in the UK in 2000 alone21, which is roughly seven people a day.
About Servier
- Servier Laboratories Ltd is the UK subsidiary of the Servier Research Group, the leading independent French research based pharmaceutical company established in 1954 by Dr Jacques Servier.
- Established in 140 countries, The Servier Research Group has annual sales worldwide of over 3.5 billion euros.
- The key franchises of the Servier Research Group are Cardiovascular disease, Diabetes, Rheumatology, Central Nervous System and Oncology.
- Servier is a research based company which seeks to fulfil unmet patient need.
- Servier earmarks 25% of its turnover for research and development every year, which is considerably higher than the industry average.
- Foundation status provides Servier with the opportunity to focus on the development of innovative drugs.
servier.co.uk
References
1. EMEA website emea.europa.eu/pdfs/human/opinion/Valdoxan_57541108en.pdf (Date Last Accessed: 21 November 2008)
2. Montgomery SA and Kasper S. Int Clin Psychopharmacol. 2007; 22: 283-291
3. Ohayon MM, Priest RG, Guilleminault C, et al. Biol Psychiatry. 1999; 45: 300-307
4. Lemoine P, Guilleminault C and Alvarez E. J Clin Psychiatry. 2007; 68: 1723-1732
5. Oli?© JP and Kasper S. Int J Neuropsychopharmacol. 2007; 10: 661-673
6. Kennedy SH and Emsley R. Eur Neuropsychopharmacol. 2006; 16(2): 93-100
7. Kennedy SH, Rizvi S, Fulton K and Rasmussen J. J Clin Psychopharmacol. 2008; 28: 329-333
8. Kasper S, Laigle L and Bayl?© F. Eur Neuropsychopharmacol. 2008; 18(suppl4): S336. Abstract P2c022.
9. Chilman-Blair K, et al. Drugs of the Future. 2003; 28(1): 7-13
10. L??o H, Hale A and D'haenen H. Int Clin Psychopharmacol. 2002; 17: 239-247
11. Leproult R, Van Ondergergen A, L'Hermite-Bal?©riaux M, et al. Clin Endocrinol. 2005; 63: 298-304
12. Stahl S. Int Journal of Psychopharmacol. 2007; 10: 575-578
13. Data on File 07VADOF126
14. Montgomery Kennedy SH, Burrows GD, et al. Int Clin Psychopharmacol. 2004; 19: 271-280.
15. Data on File 08VAL0094
16. NICE depression guideline, Questions and Answers Depression and Anxiety nice.uk/nicemedia/pdf/CG022%20and%20CG023_QandA.pdf
(Date Last Accessed: 20 November 2008)
17. Mind Information Booklet: Understanding Depression.
mind.uk/Information/Bookletes/Understanding/Understanding+depression.htm
(Date Last Accessed: 20 November 2008)
18. Quality and Outcomes Framework, Revisions to the GMS Contract 2006-7
bma.uk/ap.nsf/Content/revisionnGMSFeb20062
(Date Last Accessed: 20 November 2008)
19. Moussavi S, Chatterji S, Verdes E, et al. Lancet. 2007; 370: 851??????"858
20. Scott J. British Medical Journal. .2006; 332: 985-986
21. Thomas C and Morris S. British Journal of Psychiatry. 2003; 183: 514-519.
Source
Katie Silverwood
Reynolds-MacKenzie
130 Shaftesbury Avenue
London W1D 5EU
reynoldsmackenzie
четверг, 21 июля 2011 г.
Iraq, Afghanistan Veterans Should Be Evaluated In Long-Term Studies To Better Understand TBI, IOM Recommends
Many of the service members who experience traumatic brain injuries in Iraq and Afghanistan are at risk for long-term health problems such as depression and dementia, but it is unknown how high those risks are, according to an Institute of Medicine report released Thursday, the AP/Minneapolis Star-Tribune reports (Neergaard, AP/Minneapolis Star-Tribune, 12/5). An estimated 5,500 military personnel have suffered from a brain injury, and brain injuries account for about 22% of all casualties in Iraq and Afghanistan (Carey, New York Times, 12/5). For the IOM report, researchers examined past studies on TBI and found that it can be linked to long-term health risks such as depression, Alzheimer's-like dementia, Parkinson's-like symptoms, seizures, aggressive behavior, dizziness, amnesia and problems with social functioning (AP/Minneapolis Star-Tribune, 12/5).
The report recommended that the Department of Defense and Department of Veterans Affairs conduct further studies "to confirm reports of long-term or latent effects of exposure to blasts" to better understand and treat TBI (New York Times, 12/5). The report suggested that the departments conduct cognitive skills tests on both pre- and post-deployment soldiers to compare the long-term effects of brain injuries. In addition, every soldier exposed to a blast, regardless of its size, should be screened for TBI, the report recommended. IOM also recommended that VA establish a registry of service members with TBI to identify long-term risk factors that improve or worsen outcomes and compare them to troops with non-brain injuries (AP/Minneapolis Star-Tribune, 12/5).
Brig. Gen. Loree Sutton, director of the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, said there was "no daylight between the recommendations and actions the Department of Defense has taken already" to better evaluate brain injuries (New York Times, 12/5). VA is considering the recommendations and has 60 days to decide whether the long-term health risks will be a presumed link to the military service of veterans who experienced brain injuries.
Lead author George Rutherford of the University of California-San Francisco said, "I don't think we really knew how big a hole in scientific knowledge there is about blast-induced brain injuries" (AP/Minneapolis Star-Tribune, 12/5).
An abstract of the report is available online.
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
The report recommended that the Department of Defense and Department of Veterans Affairs conduct further studies "to confirm reports of long-term or latent effects of exposure to blasts" to better understand and treat TBI (New York Times, 12/5). The report suggested that the departments conduct cognitive skills tests on both pre- and post-deployment soldiers to compare the long-term effects of brain injuries. In addition, every soldier exposed to a blast, regardless of its size, should be screened for TBI, the report recommended. IOM also recommended that VA establish a registry of service members with TBI to identify long-term risk factors that improve or worsen outcomes and compare them to troops with non-brain injuries (AP/Minneapolis Star-Tribune, 12/5).
Brig. Gen. Loree Sutton, director of the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, said there was "no daylight between the recommendations and actions the Department of Defense has taken already" to better evaluate brain injuries (New York Times, 12/5). VA is considering the recommendations and has 60 days to decide whether the long-term health risks will be a presumed link to the military service of veterans who experienced brain injuries.
Lead author George Rutherford of the University of California-San Francisco said, "I don't think we really knew how big a hole in scientific knowledge there is about blast-induced brain injuries" (AP/Minneapolis Star-Tribune, 12/5).
An abstract of the report is available online.
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
вторник, 19 июля 2011 г.
Screening For Depression In The Workplace
Enhanced and systematic efforts to identify and treat depression in the workplace significantly improves employee health and productivity, likely leading to lower costs overall for the employer, according to a study published in the Journal of the American Medical Association. The study was funded by the National Institutes of Health's National Institute of Mental Health (NIMH).
Previous studies have shown that employees who are depressed are less productive and are absent more often. Other studies have shown that organized screening and enhanced depression treatment can significantly improve health. However, few employers have implemented such programs, in part because their return on investment is unclear.
"This study provides compelling evidence of the importance of workplace depression screening, outreach, and enhanced treatment," said NIMH Director Thomas R. Insel, M.D. "It is in the interest of workers' health and the company's bottom line to ensure depressed employees are effectively treated."
Philip Wang, M.D., Dr.P.H., director of NIMH's Division of Services and Intervention Research, and colleagues conducted a trial with 604 employees enrolled in a managed behavioral health care plan, all of whom were identified as having clinically significant depression during a Web-based and telephone screening process. Half of the participants were randomly assigned to an intervention that included telephone support from a care manager and their choice of telephone psychotherapy, in-person psychotherapy or antidepressant medication. The other half of the participants were assigned to usual care, which included feedback about their screening results, and advice to seek care from their usual provider.
After 12 months, those in the intervention group were 40 percent more likely to have recovered from their depression compared to those in usual care. Participants in the intervention group also were 70 percent more likely to stay employed, and worked an average of two more hours per week than those in usual care.
Although the data did not lend itself to a comprehensive cost/benefit analysis, the researchers noted that just the value of more hours worked among those in the intervention group who were employed, estimated at $1,800 per employee per year, far exceeds the $100-$400 per person costs associated with the type of outreach and intervention program used in the study.
"For many people, a large chunk of their lives is devoted to work. Depression affects not only a person's health, but also his or her ability to work," noted Dr. Wang. "Employers should consider a depression screening and intervention program as a healthy, win-win investment."
The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website, nimh.nih/.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih/.
Reference: Wang PS, Simon GE, Avorn J, Azocar F, Ludman EJ, McCulloch J, Petukhova MZ, Kessler RC. Telephone screening, outreach and care management for depressed workers and impact on clinical and work productivity outcomes, a randomized controlled trial. Journal of the American Medical Association, Sept 26, 2007; 298(12): 1401-11.
Previous studies have shown that employees who are depressed are less productive and are absent more often. Other studies have shown that organized screening and enhanced depression treatment can significantly improve health. However, few employers have implemented such programs, in part because their return on investment is unclear.
"This study provides compelling evidence of the importance of workplace depression screening, outreach, and enhanced treatment," said NIMH Director Thomas R. Insel, M.D. "It is in the interest of workers' health and the company's bottom line to ensure depressed employees are effectively treated."
Philip Wang, M.D., Dr.P.H., director of NIMH's Division of Services and Intervention Research, and colleagues conducted a trial with 604 employees enrolled in a managed behavioral health care plan, all of whom were identified as having clinically significant depression during a Web-based and telephone screening process. Half of the participants were randomly assigned to an intervention that included telephone support from a care manager and their choice of telephone psychotherapy, in-person psychotherapy or antidepressant medication. The other half of the participants were assigned to usual care, which included feedback about their screening results, and advice to seek care from their usual provider.
After 12 months, those in the intervention group were 40 percent more likely to have recovered from their depression compared to those in usual care. Participants in the intervention group also were 70 percent more likely to stay employed, and worked an average of two more hours per week than those in usual care.
Although the data did not lend itself to a comprehensive cost/benefit analysis, the researchers noted that just the value of more hours worked among those in the intervention group who were employed, estimated at $1,800 per employee per year, far exceeds the $100-$400 per person costs associated with the type of outreach and intervention program used in the study.
"For many people, a large chunk of their lives is devoted to work. Depression affects not only a person's health, but also his or her ability to work," noted Dr. Wang. "Employers should consider a depression screening and intervention program as a healthy, win-win investment."
The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website, nimh.nih/.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih/.
Reference: Wang PS, Simon GE, Avorn J, Azocar F, Ludman EJ, McCulloch J, Petukhova MZ, Kessler RC. Telephone screening, outreach and care management for depressed workers and impact on clinical and work productivity outcomes, a randomized controlled trial. Journal of the American Medical Association, Sept 26, 2007; 298(12): 1401-11.
воскресенье, 17 июля 2011 г.
FDA Clears Neurostar® TMS Therapy For The Treatment Of Depression
Neuronetics, Inc., a privately-held medical device
company and a leader in the field of neuromodulation, announced today that the U.S.
Food and Drug Administration (FDA) has cleared its NeuroStar TMS (Transcranial
Magnetic Stimulation) Therapy system for the treatment of depression. NeuroStar TMS
Therapy® is specifically indicated for the treatment of Major Depressive Disorder in adult
patients who have failed to achieve satisfactory improvement from one prior
antidepressant medication at or above the minimal effective dose and duration in the
current episode. In clinical trials with NeuroStar TMS Therapy, these patients had been
treated with a median of 4 medication treatment attempts, one of which achieved criteria
for adequate dose and duration.
"Clinical neuroscience advances have greatly improved the diagnosis and treatment of
depression, but much more is needed. These disorders lead the world in producing
disability, and more than half of the millions being treated for clinical depression currently
fail to achieve wellness," said John Greden, MD, Professor of Psychiatry & Clinical
Neurosciences and Executive Director of the University of Michigan Comprehensive
Depression Center. "Before now, few options have been available for them other than
complex and often unproven combinations of medications. Now, with the FDA clearance
of NeuroStar TMS Therapy, there is new hope."
The NeuroStar TMS Therapy system is the first and only TMS Therapy® device cleared
by the FDA for the treatment of depression. TMS Therapy is a non-systemic (does not
circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation which stimulates nerve cells in an area of the brain
that is linked to depression, by delivering highly focused MRI-strength magnetic pulses.
Patients being treated by NeuroStar TMS Therapy do not require anesthesia or sedation
and remain awake and alert. It is a 40-minute outpatient procedure that is prescribed by
a psychiatrist and performed in a psychiatrist's office. The treatment is typically
administered daily for 4-6 weeks.
"In the randomized controlled trial conducted for FDA clearance, NeuroStar TMS
Therapy demonstrated statistically and clinically significant treatment effects," said Phil
Janicak, MD, Professor of Psychiatry at Rush University-Chicago and a Principal
Investigator in the NeuroStar TMS Therapy clinical trials. "It's particularly noteworthy
that these outcomes were achieved without systemic side effects, such as weight gain
and sexual dysfunction."
Clinical Trials Demonstrated Efficacy and Safety of NeuroStar TMS Therapy
NeuroStar TMS Therapy was evaluated for efficacy, safety, and tolerability in the acute
treatment of major depression in patients who had failed to receive benefit from prior
antidepressant medications. A 6-week, randomized, placebo-controlled, double-blind,
study1 was conducted to evaluate the safe and effective use of NeuroStar TMS as a
monotherapy. An analysis for predictors of response demonstrated that the patients with
the best response to NeuroStar TMS Therapy were those who had not benefited from
one prior antidepressant medication at an adequate dose and duration in the current
episode2. These are the patients for whom NeuroStar TMS Therapy has been cleared
by the FDA.
This clinical study population2 was comprised of 164 patients with unipolar, non-psychotic
major depressive disorder. Almost all of them (97%) had suffered previous depression
episodes. These patients also had an extensive treatment history without a satisfactory
improvement. They had received a median of 4 total prior antidepressant treatment
attempts in the current episode, one of which achieved treatment adequacy at or above the
minimal effective dose and duration. Forty-eight percent were unemployed due to their
depression, 35% had a co-morbid anxiety disorder, and all had moderate to severe
depressive symptoms.
In the indicated patient population, the following efficacy results were observed in the
randomized, controlled study:
- The primary efficacy measure, the Montgomery-Asberg Depression Rating Scale
(MADRS) symptom score change at 4 weeks, was statistically significantly
superior to placebo (p=0.0006), among NeuroStar-treated patients. Similar
results were observed with the Hamilton Depression Rating Scale (HAMD) 3.
- NeuroStar TMS Therapy-treated patients had statistically significant response3
and remission4 rates, which were approximately twice the rate of placebo-treated
patients. The response rate is the percentage of patients who had a >50%
improvement in symptoms, and the remission rate is the percentage of patients
who achieved virtually complete symptom resolution.
- NeuroStar TMS Therapy also produced statistically significant improvements on
the HAMD factor scores for core depression symptoms, anxiety symptoms,
somatization, and psychomotor retardation.4
Throughout the NeuroStar TMS Therapy studies, more than 10,000 active TMS
treatments were safely performed. The following were the safety results observed5:
- No systemic side effects, such as weight gain, sexual dysfunction, sedation, nausea,
or dry mouth
- No adverse effects on concentration or memory
- No seizures
- No device-drug interactions
- The most common adverse event related to treatment was scalp pain or discomfort
at the treatment area during active treatments, which was transient and mild to
moderate in severity. The incidence of this side effect declined markedly after the
first week of treatment.
- There was a less than 5% discontinuation rate due to adverse events.
- During a 6-month follow-up period, there were no new safety observations compared
to those seen during acute treatment.
NeuroStar TMS Therapy is contraindicated in patients with implanted metallic devices or
non-removable metallic objects in or around the head. As with any antidepressant
treatment, patients should be monitored for symptoms of worsening depression.
NeuroStar TMS Therapy has not been studied in patients who have not received prior antidepressant treatment. Efficacy has not been established in patients who have failed
to receive benefit from two or more prior antidepressant treatments at minimal effective
dose and duration in the current episode.
"Depression is a debilitating illness, and existing treatment options are frequently
ineffective or intolerable due to side effects," said Neuronetics' President and CEO,
Bruce Shook. "The availability of NeuroStar TMS Therapy means that patients suffering
from this disease now have an entirely new non-systemic and non-invasive treatment
option that has been proven safe and effective."
Availability of NeuroStar TMS Therapy
Initially, NeuroStar TMS Therapy will only be available in a limited number of treatment
centers around the country. For specific information on treatment locations with
NeuroStar TMS Therapy, please visit NeuroStarTMS.
About Depression
Depression affects at least 14 million American adults each year. Researchers estimate
that by the year 2020, depression will be the second leading cause of disability
worldwide. Each year, over 30,000 people in the US commit suicide, 60% of which
suffer from depression. The economic burden of depression in 2000 was estimated at
$83.1 billion in the US. Women are almost twice as likely as men to suffer from
depression. However, some experts feel that depression in men is under-reported.
Depression has no racial, ethnic, or socioeconomic boundaries. About two-thirds of
those who experience an episode of depression will have at least one other episode in
their lives. Despite major advances in treating this debilitating illness, nearly 30% of
patients with depression do not benefit from or are intolerant of antidepressant therapy.
About Neuronetics
Neuronetics, Inc. is a privately-held medical device company focused on developing
non-invasive therapies for psychiatric and neurological disorders using MRI-strength
magnetic field pulses. Based in Malvern, PA., Neuronetics is the leader in the
development of TMS Therapy, a non-invasive form of neuromodulation. For more
information, please visit neuronetics.
References
1. O'Reardon, J,et al. Efficacy and Safety of Transcranial Magnetic Stimulation Therapy in the Acute Treatment of Major
Depression: A Multi-site Randomized Controlled Trial. Biological Psychiatry, December 2007; 62:1208-1216.
2. Lisanby, S, et al. Daily Left Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) in the Acute Treatment of
Major Depression: Clinical Predictors of Outcome in a Multisite, Randomized Controlled Clinical Trial.
Neuropsychopharmacology, advance online publication, 13 August 2008; doi:10.1038/npp.2008.118.
3. Thase M, Demitrack M. Evaluating Clinical Significance of Treatment Outcomes in Studies of Resistant Major
Depression, Biological Psychiatry, April, 2008; Vol. 63:7s, pg. 138s.
4. Data on file.
5. Janicak, P, et al. Transcranial Magnetic Stimulation (TMS) in the Treatment of Major Depression: A Comprehensive
Summary of Safety Experience from Acute Exposure, Extended Exposure and During Reintroduction Treatment. Journal
of Clinical Psychiatry, February 2008; 69:2:222-232.
NeuroStar®, NeuroStar TMS Therapy®, and TMS Therapy® are registered trademarks of Neuronetics, Inc.
Neuronetics
company and a leader in the field of neuromodulation, announced today that the U.S.
Food and Drug Administration (FDA) has cleared its NeuroStar TMS (Transcranial
Magnetic Stimulation) Therapy system for the treatment of depression. NeuroStar TMS
Therapy® is specifically indicated for the treatment of Major Depressive Disorder in adult
patients who have failed to achieve satisfactory improvement from one prior
antidepressant medication at or above the minimal effective dose and duration in the
current episode. In clinical trials with NeuroStar TMS Therapy, these patients had been
treated with a median of 4 medication treatment attempts, one of which achieved criteria
for adequate dose and duration.
"Clinical neuroscience advances have greatly improved the diagnosis and treatment of
depression, but much more is needed. These disorders lead the world in producing
disability, and more than half of the millions being treated for clinical depression currently
fail to achieve wellness," said John Greden, MD, Professor of Psychiatry & Clinical
Neurosciences and Executive Director of the University of Michigan Comprehensive
Depression Center. "Before now, few options have been available for them other than
complex and often unproven combinations of medications. Now, with the FDA clearance
of NeuroStar TMS Therapy, there is new hope."
The NeuroStar TMS Therapy system is the first and only TMS Therapy® device cleared
by the FDA for the treatment of depression. TMS Therapy is a non-systemic (does not
circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation which stimulates nerve cells in an area of the brain
that is linked to depression, by delivering highly focused MRI-strength magnetic pulses.
Patients being treated by NeuroStar TMS Therapy do not require anesthesia or sedation
and remain awake and alert. It is a 40-minute outpatient procedure that is prescribed by
a psychiatrist and performed in a psychiatrist's office. The treatment is typically
administered daily for 4-6 weeks.
"In the randomized controlled trial conducted for FDA clearance, NeuroStar TMS
Therapy demonstrated statistically and clinically significant treatment effects," said Phil
Janicak, MD, Professor of Psychiatry at Rush University-Chicago and a Principal
Investigator in the NeuroStar TMS Therapy clinical trials. "It's particularly noteworthy
that these outcomes were achieved without systemic side effects, such as weight gain
and sexual dysfunction."
Clinical Trials Demonstrated Efficacy and Safety of NeuroStar TMS Therapy
NeuroStar TMS Therapy was evaluated for efficacy, safety, and tolerability in the acute
treatment of major depression in patients who had failed to receive benefit from prior
antidepressant medications. A 6-week, randomized, placebo-controlled, double-blind,
study1 was conducted to evaluate the safe and effective use of NeuroStar TMS as a
monotherapy. An analysis for predictors of response demonstrated that the patients with
the best response to NeuroStar TMS Therapy were those who had not benefited from
one prior antidepressant medication at an adequate dose and duration in the current
episode2. These are the patients for whom NeuroStar TMS Therapy has been cleared
by the FDA.
This clinical study population2 was comprised of 164 patients with unipolar, non-psychotic
major depressive disorder. Almost all of them (97%) had suffered previous depression
episodes. These patients also had an extensive treatment history without a satisfactory
improvement. They had received a median of 4 total prior antidepressant treatment
attempts in the current episode, one of which achieved treatment adequacy at or above the
minimal effective dose and duration. Forty-eight percent were unemployed due to their
depression, 35% had a co-morbid anxiety disorder, and all had moderate to severe
depressive symptoms.
In the indicated patient population, the following efficacy results were observed in the
randomized, controlled study:
- The primary efficacy measure, the Montgomery-Asberg Depression Rating Scale
(MADRS) symptom score change at 4 weeks, was statistically significantly
superior to placebo (p=0.0006), among NeuroStar-treated patients. Similar
results were observed with the Hamilton Depression Rating Scale (HAMD) 3.
- NeuroStar TMS Therapy-treated patients had statistically significant response3
and remission4 rates, which were approximately twice the rate of placebo-treated
patients. The response rate is the percentage of patients who had a >50%
improvement in symptoms, and the remission rate is the percentage of patients
who achieved virtually complete symptom resolution.
- NeuroStar TMS Therapy also produced statistically significant improvements on
the HAMD factor scores for core depression symptoms, anxiety symptoms,
somatization, and psychomotor retardation.4
Throughout the NeuroStar TMS Therapy studies, more than 10,000 active TMS
treatments were safely performed. The following were the safety results observed5:
- No systemic side effects, such as weight gain, sexual dysfunction, sedation, nausea,
or dry mouth
- No adverse effects on concentration or memory
- No seizures
- No device-drug interactions
- The most common adverse event related to treatment was scalp pain or discomfort
at the treatment area during active treatments, which was transient and mild to
moderate in severity. The incidence of this side effect declined markedly after the
first week of treatment.
- There was a less than 5% discontinuation rate due to adverse events.
- During a 6-month follow-up period, there were no new safety observations compared
to those seen during acute treatment.
NeuroStar TMS Therapy is contraindicated in patients with implanted metallic devices or
non-removable metallic objects in or around the head. As with any antidepressant
treatment, patients should be monitored for symptoms of worsening depression.
NeuroStar TMS Therapy has not been studied in patients who have not received prior antidepressant treatment. Efficacy has not been established in patients who have failed
to receive benefit from two or more prior antidepressant treatments at minimal effective
dose and duration in the current episode.
"Depression is a debilitating illness, and existing treatment options are frequently
ineffective or intolerable due to side effects," said Neuronetics' President and CEO,
Bruce Shook. "The availability of NeuroStar TMS Therapy means that patients suffering
from this disease now have an entirely new non-systemic and non-invasive treatment
option that has been proven safe and effective."
Availability of NeuroStar TMS Therapy
Initially, NeuroStar TMS Therapy will only be available in a limited number of treatment
centers around the country. For specific information on treatment locations with
NeuroStar TMS Therapy, please visit NeuroStarTMS.
About Depression
Depression affects at least 14 million American adults each year. Researchers estimate
that by the year 2020, depression will be the second leading cause of disability
worldwide. Each year, over 30,000 people in the US commit suicide, 60% of which
suffer from depression. The economic burden of depression in 2000 was estimated at
$83.1 billion in the US. Women are almost twice as likely as men to suffer from
depression. However, some experts feel that depression in men is under-reported.
Depression has no racial, ethnic, or socioeconomic boundaries. About two-thirds of
those who experience an episode of depression will have at least one other episode in
their lives. Despite major advances in treating this debilitating illness, nearly 30% of
patients with depression do not benefit from or are intolerant of antidepressant therapy.
About Neuronetics
Neuronetics, Inc. is a privately-held medical device company focused on developing
non-invasive therapies for psychiatric and neurological disorders using MRI-strength
magnetic field pulses. Based in Malvern, PA., Neuronetics is the leader in the
development of TMS Therapy, a non-invasive form of neuromodulation. For more
information, please visit neuronetics.
References
1. O'Reardon, J,et al. Efficacy and Safety of Transcranial Magnetic Stimulation Therapy in the Acute Treatment of Major
Depression: A Multi-site Randomized Controlled Trial. Biological Psychiatry, December 2007; 62:1208-1216.
2. Lisanby, S, et al. Daily Left Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) in the Acute Treatment of
Major Depression: Clinical Predictors of Outcome in a Multisite, Randomized Controlled Clinical Trial.
Neuropsychopharmacology, advance online publication, 13 August 2008; doi:10.1038/npp.2008.118.
3. Thase M, Demitrack M. Evaluating Clinical Significance of Treatment Outcomes in Studies of Resistant Major
Depression, Biological Psychiatry, April, 2008; Vol. 63:7s, pg. 138s.
4. Data on file.
5. Janicak, P, et al. Transcranial Magnetic Stimulation (TMS) in the Treatment of Major Depression: A Comprehensive
Summary of Safety Experience from Acute Exposure, Extended Exposure and During Reintroduction Treatment. Journal
of Clinical Psychiatry, February 2008; 69:2:222-232.
NeuroStar®, NeuroStar TMS Therapy®, and TMS Therapy® are registered trademarks of Neuronetics, Inc.
Neuronetics
пятница, 15 июля 2011 г.
Maternal Depression Linked To Sudden Infant Death Syndrome
Depression during pregnancy, and after birth, is associated with Sudden Infant Death Syndrome (SIDS), particularly if the mother is depressed in the year before delivery, according to a new study, presented today and due to be published later this year in the Journal of Clinical Psychology.
SIDS has been linked to psychiatric disorders in 3 studies, but these have had a number of limitations. This study set out to investigate whether there is an association between SIDS and mental illness.
It compared two groups of women. The first were women registered with a general practice on the General Practice Research Database (GPRD) who had a live birth between 1987 and 2000 and who had an infant who died unexpectedly in the first year of life, with a diagnosis of SIDS.
The second (control) group was made up of women matched for age, registered with the same general practices on the GPRD with a live birth born in the same year as a SIDS baby, but whose babies survived the first year of life.
The researchers analysed the effect of maternal psychiatric disorders and other possible risk factors.
169 mother-infant cases of SIDS were matched with 662 mother-infant controls. SIDS was found to be independently associated with a history of depression in the year before birth, smoking, and male gender. There was also weaker evidence of an association of SIDS with depression in the 6 months after birth.
The researchers conclude that women with depression during and after pregnancy need their depression identified and treated. Healthcare professionals treating them need to provide clear advice on infant care practices that may prevent SIDS. Factors mediating the association between maternal depression and SIDS need further investigation.
Royal College of Psychiatrists
SIDS has been linked to psychiatric disorders in 3 studies, but these have had a number of limitations. This study set out to investigate whether there is an association between SIDS and mental illness.
It compared two groups of women. The first were women registered with a general practice on the General Practice Research Database (GPRD) who had a live birth between 1987 and 2000 and who had an infant who died unexpectedly in the first year of life, with a diagnosis of SIDS.
The second (control) group was made up of women matched for age, registered with the same general practices on the GPRD with a live birth born in the same year as a SIDS baby, but whose babies survived the first year of life.
The researchers analysed the effect of maternal psychiatric disorders and other possible risk factors.
169 mother-infant cases of SIDS were matched with 662 mother-infant controls. SIDS was found to be independently associated with a history of depression in the year before birth, smoking, and male gender. There was also weaker evidence of an association of SIDS with depression in the 6 months after birth.
The researchers conclude that women with depression during and after pregnancy need their depression identified and treated. Healthcare professionals treating them need to provide clear advice on infant care practices that may prevent SIDS. Factors mediating the association between maternal depression and SIDS need further investigation.
Royal College of Psychiatrists
среда, 13 июля 2011 г.
Study Contradicts USA Warning That An Antidepressant Can Cause Congenital Abnormalities
A study carried out by German researchers has failed to show that a popular antidepressant, paroxetine®, causes congenital abnormalities if taken by pregnant women, the 22nd annual conference of the European Society of Human Reproduction and Embryology heard.
Dr Wolfgang Paulus said the results were important because they contradicted a warning issued by the US Food and Drug Administration in October 2005 that the use of paroxetine (brand names: Seroxat®, Paxil®, Aropax®, Deroxat® or Pondera®) could increase the risk of major congenital abnormalities. The warning may have caused women to terminate their pregnancies unnecessarily.
Dr Paulus, director of the Institute of Reproductive Toxicology at the University of Ulm, Germany, told a news briefing: "Our results show the importance of a reliable pharmaco-vigilance system documenting foetal outcome after medication in pregnancy. We need international networks of registries to do this, but financial support for this purpose is lacking. We hope for more serious efforts from the pharmaceutical industry and governmental authorities in Europe. We think that this is also an ethical challenge because many patients opt for termination of pregnancy due to fear of congenital malformations.
The FDA warning about the drug, which is a selective serotonin reuptake inhibitor (SSRI), was issued on the basis of unpublished research. "It showed that the absolute rate of major congenital malformations seen in the first trimester for paroxetine® users was 4%, and 2% for cardiovascular malformations. Yet the retrospective study of 5,956 women by the producer, GlaxoSmithKline, had only 591 cases of medication with paroxetine® during the first trimester and did not include controls of women not taking an antidepressant," he said.*
In contrast, the research carried out by Dr Paulus and his colleagues was a prospective follow-up study that collected data on pregnancy outcomes after medication with paroxetine® in 119 women between 1990 and 2005. "Our national Teratology Information Service (TIS) was contacted by physicians and patients after exposure to paroxetine® in the first trimester of pregnancy. We compared the results with a control group of 645 women over the same period of time, who had not been exposed, or not severely exposed, to the drug.
"We found that the rate of congenital abnormalities was not increased after using paroxetine® in early pregnancy. Three abnormalities were reported after exposure to paroxetine®: club feet after exposure throughout pregnancy, a large port wine mark after exposure up to the seventh week, and spastic torticollis (painful spasms of the neck muscles) after exposure in the first twelve weeks. However, in the non-paroxetine® group there was a similar rate of abnormalities, with 25 out of 557 babies affected."
However, the researchers did find that the number of women deciding to terminate their pregnancies was much higher amongst the paroxetine group. "Eighteen out of 119 paroxetine users (just over 15%) preferred termination of pregnancy compared to 17 out of 645 women in the control group (2.6%). In most cases the patients opted for termination of pregnancy because of a combination of reasons: partly because of their depression, but also because of confusion caused by information on possible damage to the foetus from the package labelling.
"Our prospective controlled follow-up study does not support the assumption that paroxetine® can cause congenital abnormalities. Although our study of 119 paroxetine users was relatively small, there are three other, peer-reviewed, published studies that show no increased rates of cardiovascular malformations with paroxetine®, whereas there has been no published research that shows that paroxetine can cause abnormalities. We continue collecting data as a member of the European Network of Teratology Services (ENTIS) in order to reassure patients who need a long-term antidepressant medication."
Dr Paulus highlighted the damage that incomplete research can have not only on the unborn babies, through decisions to terminate pregnancies, but also on the mental and physical well-being of mothers, through not treating their depression or stopping their medication abruptly.
"Depression, anxiety, obsessive-compulsive disorder and premenstrual stress are common disorders during child-bearing years and can be treated with antidepressants such as paroxetine®. Failure to treat depression during pregnancy can have significant negative ramifications for both mother and child. Women and their physicians should discuss this information and make an informed decision, whether or not to continue with paroxetine® during pregnancy. Concerned patients can be offered ultrasound and echocardiogram, which can rule out foetal cardiac problems in early pregnancy. Antidepressants should never be stopped abruptly as this can have serious ramifications for the mother. If a woman does decide, following a discussion with her physician, that she wants to discontinue paroxetine®, the drug should be slowly tapered off."
Notes
The rate of major congenital malformations in the normal population in the USA is 3% and 1% for cardiovascular malformations.
Abstract no: O-030, Monday 10.45-11.00 hrs CET (Small Hall, Level 0)
Contact: Emma Mason
European Society for Human Reproduction and Embryology
View drug information on Paxil CR.
Dr Wolfgang Paulus said the results were important because they contradicted a warning issued by the US Food and Drug Administration in October 2005 that the use of paroxetine (brand names: Seroxat®, Paxil®, Aropax®, Deroxat® or Pondera®) could increase the risk of major congenital abnormalities. The warning may have caused women to terminate their pregnancies unnecessarily.
Dr Paulus, director of the Institute of Reproductive Toxicology at the University of Ulm, Germany, told a news briefing: "Our results show the importance of a reliable pharmaco-vigilance system documenting foetal outcome after medication in pregnancy. We need international networks of registries to do this, but financial support for this purpose is lacking. We hope for more serious efforts from the pharmaceutical industry and governmental authorities in Europe. We think that this is also an ethical challenge because many patients opt for termination of pregnancy due to fear of congenital malformations.
The FDA warning about the drug, which is a selective serotonin reuptake inhibitor (SSRI), was issued on the basis of unpublished research. "It showed that the absolute rate of major congenital malformations seen in the first trimester for paroxetine® users was 4%, and 2% for cardiovascular malformations. Yet the retrospective study of 5,956 women by the producer, GlaxoSmithKline, had only 591 cases of medication with paroxetine® during the first trimester and did not include controls of women not taking an antidepressant," he said.*
In contrast, the research carried out by Dr Paulus and his colleagues was a prospective follow-up study that collected data on pregnancy outcomes after medication with paroxetine® in 119 women between 1990 and 2005. "Our national Teratology Information Service (TIS) was contacted by physicians and patients after exposure to paroxetine® in the first trimester of pregnancy. We compared the results with a control group of 645 women over the same period of time, who had not been exposed, or not severely exposed, to the drug.
"We found that the rate of congenital abnormalities was not increased after using paroxetine® in early pregnancy. Three abnormalities were reported after exposure to paroxetine®: club feet after exposure throughout pregnancy, a large port wine mark after exposure up to the seventh week, and spastic torticollis (painful spasms of the neck muscles) after exposure in the first twelve weeks. However, in the non-paroxetine® group there was a similar rate of abnormalities, with 25 out of 557 babies affected."
However, the researchers did find that the number of women deciding to terminate their pregnancies was much higher amongst the paroxetine group. "Eighteen out of 119 paroxetine users (just over 15%) preferred termination of pregnancy compared to 17 out of 645 women in the control group (2.6%). In most cases the patients opted for termination of pregnancy because of a combination of reasons: partly because of their depression, but also because of confusion caused by information on possible damage to the foetus from the package labelling.
"Our prospective controlled follow-up study does not support the assumption that paroxetine® can cause congenital abnormalities. Although our study of 119 paroxetine users was relatively small, there are three other, peer-reviewed, published studies that show no increased rates of cardiovascular malformations with paroxetine®, whereas there has been no published research that shows that paroxetine can cause abnormalities. We continue collecting data as a member of the European Network of Teratology Services (ENTIS) in order to reassure patients who need a long-term antidepressant medication."
Dr Paulus highlighted the damage that incomplete research can have not only on the unborn babies, through decisions to terminate pregnancies, but also on the mental and physical well-being of mothers, through not treating their depression or stopping their medication abruptly.
"Depression, anxiety, obsessive-compulsive disorder and premenstrual stress are common disorders during child-bearing years and can be treated with antidepressants such as paroxetine®. Failure to treat depression during pregnancy can have significant negative ramifications for both mother and child. Women and their physicians should discuss this information and make an informed decision, whether or not to continue with paroxetine® during pregnancy. Concerned patients can be offered ultrasound and echocardiogram, which can rule out foetal cardiac problems in early pregnancy. Antidepressants should never be stopped abruptly as this can have serious ramifications for the mother. If a woman does decide, following a discussion with her physician, that she wants to discontinue paroxetine®, the drug should be slowly tapered off."
Notes
The rate of major congenital malformations in the normal population in the USA is 3% and 1% for cardiovascular malformations.
Abstract no: O-030, Monday 10.45-11.00 hrs CET (Small Hall, Level 0)
Contact: Emma Mason
European Society for Human Reproduction and Embryology
View drug information on Paxil CR.
понедельник, 11 июля 2011 г.
Depression Affects How Women With PMDD Respond To Stress, Pain
As science slowly, but continually, unravels the causes of disorders, it increasingly teases apart biological threads that, when spooled together, begin to take on the warp and weft of separate disorders.
Add to the developing fabrics a severe mood disorder, premenstrual dysphoric disorder, which affects 5 percent to 7 percent of all women of reproductive age in the United States but is often misdiagnosed as major depression or other mood disorder.
A recent study further establishes that PMDD is biologically different, and that women with PMDD who have experienced depression could make up a subset.
The findings are important because they give physicians more reason to search for a more specific diagnosis and could possibly lead to more precise treatments, of which there are currently few good choices, said Susan Girdler, Ph.D., professor of psychiatry at the University of North Carolina at Chapel Hill School of Medicine who led the study.
"PMDD is not garden-variety premenstrual symptoms. PMDD causes severe impairment in quality of life, equivalent to post-traumatic stress disorder, major depressive disorder and panic disorder, that continually cycles on a monthly basis. Some women spend half their lives suffering from this disorder," said Girdler, who also is director of the Stress and Health Research Program in UNC's Center for Women's Mood Disorders.
In a study published ahead of print in the journal Biological Psychology, Girdler and her colleagues measured biological responses to stress and pain. Previous studies demonstrated that women with chronic major depression have a heightened biological response to stress and release more stress hormones, such as cortisol. And, Girdler and her group have previously shown that women with PMDD respond conversely, with blunted stress responses.
The current study is the first known head-to-head comparison of the two groups and confirmed earlier findings.
"We found the greatest weight of evidence that PMDD and major depression are really two distinct entities in terms of biological response to stress and with respect to pain sensitivity and pain mechanisms," Girdler said.
But more important, Girdler said, was the finding that women with PMDD who also had experienced depression in the past looked different from PMDD women who had never been depressed. Only the PMDD women with prior depression had lower cortisol and greater sensitivity to pain compared to non-PMDD women with prior depression. These differences between PMDD and non-PMDD women were not seen in women who had no depression history.
"So while the study shows that PMDD is biologically different from major depression, a history of depression may have special relevance for women with PMDD with respect to stress hormones and pain response," Girdler said.
Current treatments for PMDD are effective in only about half of women. But, Girdler says, gathering more biological clues about PMDD could expand the treatment options.
Girdler and her colleagues are currently enrolling women with PMDD who would receive free diagnostic and medical tests, and who may be eligible for treatment studies and studies providing monetary compensation. Interested participants should call the UNC Center for Women's Mood Disorders at 919-966-2547.
UNC recently expanded the Center for Women's Mood Disorders to Rex Healthcare in Raleigh, where women can be seen for both a clinical evaluation and can be enrolled in research studies.
Source
University of North Carolina at Chapel Hill School of Medicine
Add to the developing fabrics a severe mood disorder, premenstrual dysphoric disorder, which affects 5 percent to 7 percent of all women of reproductive age in the United States but is often misdiagnosed as major depression or other mood disorder.
A recent study further establishes that PMDD is biologically different, and that women with PMDD who have experienced depression could make up a subset.
The findings are important because they give physicians more reason to search for a more specific diagnosis and could possibly lead to more precise treatments, of which there are currently few good choices, said Susan Girdler, Ph.D., professor of psychiatry at the University of North Carolina at Chapel Hill School of Medicine who led the study.
"PMDD is not garden-variety premenstrual symptoms. PMDD causes severe impairment in quality of life, equivalent to post-traumatic stress disorder, major depressive disorder and panic disorder, that continually cycles on a monthly basis. Some women spend half their lives suffering from this disorder," said Girdler, who also is director of the Stress and Health Research Program in UNC's Center for Women's Mood Disorders.
In a study published ahead of print in the journal Biological Psychology, Girdler and her colleagues measured biological responses to stress and pain. Previous studies demonstrated that women with chronic major depression have a heightened biological response to stress and release more stress hormones, such as cortisol. And, Girdler and her group have previously shown that women with PMDD respond conversely, with blunted stress responses.
The current study is the first known head-to-head comparison of the two groups and confirmed earlier findings.
"We found the greatest weight of evidence that PMDD and major depression are really two distinct entities in terms of biological response to stress and with respect to pain sensitivity and pain mechanisms," Girdler said.
But more important, Girdler said, was the finding that women with PMDD who also had experienced depression in the past looked different from PMDD women who had never been depressed. Only the PMDD women with prior depression had lower cortisol and greater sensitivity to pain compared to non-PMDD women with prior depression. These differences between PMDD and non-PMDD women were not seen in women who had no depression history.
"So while the study shows that PMDD is biologically different from major depression, a history of depression may have special relevance for women with PMDD with respect to stress hormones and pain response," Girdler said.
Current treatments for PMDD are effective in only about half of women. But, Girdler says, gathering more biological clues about PMDD could expand the treatment options.
Girdler and her colleagues are currently enrolling women with PMDD who would receive free diagnostic and medical tests, and who may be eligible for treatment studies and studies providing monetary compensation. Interested participants should call the UNC Center for Women's Mood Disorders at 919-966-2547.
UNC recently expanded the Center for Women's Mood Disorders to Rex Healthcare in Raleigh, where women can be seen for both a clinical evaluation and can be enrolled in research studies.
Source
University of North Carolina at Chapel Hill School of Medicine
суббота, 9 июля 2011 г.
Timely Depression Diagnosis Critical To Maintain Health Of Elderly
Depression affects approximately 30 to 40 percent of nursing home residents, but it often goes unrecognized, according to American Geriatrics Society, which can lead to lower quality of life or even suicide. Now, researchers at the University of Missouri have found a series of indicators, other than changes in mood that are associated with the development of depression in nursing home residents.
"Prompt diagnosis and treatment of depression is essential to improve the quality of life for nursing home residents," said Lorraine Phillips, assistant professor in the Sinclair School of Nursing. "Many elderly people develop certain clinical characteristics at the same time they develop depression. Understanding these changes is essential to quickly and accurately diagnosing depression in nursing home residents."
Changes in characteristics that Phillips found to be associated with the development of depression include increased verbal aggression, urinary incontinence, increased pain, weight loss, changes in care needs, reduced cognitive ability and decline in performance of daily living activities.
"Depression is currently diagnosed using several methods that emphasize mood symptoms including interviewing and self-reporting of depression symptoms," Phillips said. "However, since elderly depression may appear with non-mood symptoms, these characteristics identified in this study can help diagnose depression that may be overlooked by traditional screening methods."
Phillips found that residents with increased verbal aggression were 69 percent more likely to be diagnosed with depression than those who had not shown these changes. Decreases in activities of daily living, such as feeding or dressing one's self, also were associated with increased depression diagnosis. The research indicates that men and women in nursing homes are equally likely to develop depression. This contrasts with the overall population, where women are more likely than men to experience depression.
To study these changes, MU researchers analyzed data on more than 14,000 nursing home residents aged 65 and older who were not diagnosed with depression at the beginning of the study. Researchers analyzed changes in various clinical factors, other than mood changes, to discover which changes were associated with the development of depression during a three-month interval of time. The data was collected from the Missouri Minimum Data Set, a federally mandated process for clinical assessment of all residents in Medicare- or Medicaid-certified nursing homes.
Phillips worked with Marilyn Rantz, a professor in the MU Sinclair School of Nursing and chair of the MU Minimum Data Set and Quality Research Team, and Gregory Petroski, a research assistant professor and statistician in the Office of Medical Research. The study was published in the Journal of Gerontological Nursing.
"Prompt diagnosis and treatment of depression is essential to improve the quality of life for nursing home residents," said Lorraine Phillips, assistant professor in the Sinclair School of Nursing. "Many elderly people develop certain clinical characteristics at the same time they develop depression. Understanding these changes is essential to quickly and accurately diagnosing depression in nursing home residents."
Changes in characteristics that Phillips found to be associated with the development of depression include increased verbal aggression, urinary incontinence, increased pain, weight loss, changes in care needs, reduced cognitive ability and decline in performance of daily living activities.
"Depression is currently diagnosed using several methods that emphasize mood symptoms including interviewing and self-reporting of depression symptoms," Phillips said. "However, since elderly depression may appear with non-mood symptoms, these characteristics identified in this study can help diagnose depression that may be overlooked by traditional screening methods."
Phillips found that residents with increased verbal aggression were 69 percent more likely to be diagnosed with depression than those who had not shown these changes. Decreases in activities of daily living, such as feeding or dressing one's self, also were associated with increased depression diagnosis. The research indicates that men and women in nursing homes are equally likely to develop depression. This contrasts with the overall population, where women are more likely than men to experience depression.
To study these changes, MU researchers analyzed data on more than 14,000 nursing home residents aged 65 and older who were not diagnosed with depression at the beginning of the study. Researchers analyzed changes in various clinical factors, other than mood changes, to discover which changes were associated with the development of depression during a three-month interval of time. The data was collected from the Missouri Minimum Data Set, a federally mandated process for clinical assessment of all residents in Medicare- or Medicaid-certified nursing homes.
Phillips worked with Marilyn Rantz, a professor in the MU Sinclair School of Nursing and chair of the MU Minimum Data Set and Quality Research Team, and Gregory Petroski, a research assistant professor and statistician in the Office of Medical Research. The study was published in the Journal of Gerontological Nursing.
четверг, 7 июля 2011 г.
Screening Test Validated For Depression In Adolescents
Primary-care clinicians know teen depression is common, but they've lacked a reliable screening test for it. Now researchers at the University of Washington (UW), Seattle Children's, and Group Health report the PHQ-9 (Patient Health Questionnaire - 9 item) is a good screening test for major depression in adolescents.
Led by Laura P. Richardson, MD, MPH, the team tested the PHQ-9 as a screening tool for depression in 442 teenage patients, age 13-17, at Group Health. The test is brief, available free of charge, easy to score and understand, and proven to find major depression (meeting DSM-IV criteria) in adults. This study, the first to assess it in teens, is in the November 2010 Pediatrics.
"This is important not only because depression is relatively common among adolescents, but also because we have effective treatment for them," said Dr. Richardson. She is an associate professor of pediatrics at the UW, an adolescent medicine specialist at Seattle Children's, and an affiliate investigator at Group Health Research Institute. "Primary care clinicians are advised to screen teens for depression," she said, "and they need a convenient tool like this."
The team compared the PHQ-9 to the more labor-intensive gold standard, an independent structured mental health interview (the Child Diagnostic Interview Schedule, DISC-IV)-and to published data on use of the screening test in adults. They found the best cut point for maximizing the PHQ-9 screening test's sensitivity without losing specificity (11) is higher among teens than in adults. But its sensitivity (89.5%) and specificity (77.5%) in teens are similar to those in adults. So the team concluded that the PHQ-9 is an excellent choice for providers and researchers who want to screen for depression in teens in primary care.
Led by Laura P. Richardson, MD, MPH, the team tested the PHQ-9 as a screening tool for depression in 442 teenage patients, age 13-17, at Group Health. The test is brief, available free of charge, easy to score and understand, and proven to find major depression (meeting DSM-IV criteria) in adults. This study, the first to assess it in teens, is in the November 2010 Pediatrics.
"This is important not only because depression is relatively common among adolescents, but also because we have effective treatment for them," said Dr. Richardson. She is an associate professor of pediatrics at the UW, an adolescent medicine specialist at Seattle Children's, and an affiliate investigator at Group Health Research Institute. "Primary care clinicians are advised to screen teens for depression," she said, "and they need a convenient tool like this."
The team compared the PHQ-9 to the more labor-intensive gold standard, an independent structured mental health interview (the Child Diagnostic Interview Schedule, DISC-IV)-and to published data on use of the screening test in adults. They found the best cut point for maximizing the PHQ-9 screening test's sensitivity without losing specificity (11) is higher among teens than in adults. But its sensitivity (89.5%) and specificity (77.5%) in teens are similar to those in adults. So the team concluded that the PHQ-9 is an excellent choice for providers and researchers who want to screen for depression in teens in primary care.
вторник, 5 июля 2011 г.
More Than Half Of Depression Patients Give Up Their Treatment
Most patients who take anti-depressants give up their treatment in less than six months, the minimum period recommended for treating severe depression and other derived pathologies. This is the conclusion of a new study carried out by Catalan researchers, which reveals that only 25% continue their treatment for more than 11 months.
"Only one in every five patients properly completes their treatment", Catalina Serna, co-author of the study, and an expert at the Jordi Gol Primary Care Research Institute (IDIAP) in Lleida, tells SINC.
From 2003 to 2007, researchers from the Catalan Institute of Health (ICS) and the IDIAP Jordi Gol analysed 7,525 patients who were starting anti-depression treatment, looking at how long they continued with this treatment and the reasons why they gave it up.
The results, published this year in the journal European Psychiatry, pointed out that, of the 3.2% of the population who started treatment for depression, 56% stopped taking their medication during the first four months, and less than 25% of the cohort continued their treatment for more than 11 months
.
The researchers say patients are most likely to give up their medication during the acute stage of depression (the first months). "The levels to which they stick to their treatment also declines steeply between the first four and 12 months of the monitoring period", Serna points out.
"In our study, only 22% of patients completed their treatment", the expert explains. "The higher completion rates seen in chronic cases are in multiply-medicated patients, who are twice as likely as other patients to continue with their treatment for depression (31% vs. 15.3%).
Men are more likely to give up treatment
Meanwhile, men are more at risk of giving up their treatment earlier than women (50% of men gave up their medication after two months, while 50% of women gave it up after three months).
Depression is one of the commonest psychiatric diseases among adults, above all in industrialised countries. A European study carried out in 2004 found that almost 13% of individuals surveyed reported having a serious depressive illness at some point in their lives. This study revealed that in Spain, where anti-depressant use has risen in line with the availability of new drugs, 10.5% of the population suffers from depression.
Sources: Plataforma SINC, AlphaGalileo Foundation.
"Only one in every five patients properly completes their treatment", Catalina Serna, co-author of the study, and an expert at the Jordi Gol Primary Care Research Institute (IDIAP) in Lleida, tells SINC.
From 2003 to 2007, researchers from the Catalan Institute of Health (ICS) and the IDIAP Jordi Gol analysed 7,525 patients who were starting anti-depression treatment, looking at how long they continued with this treatment and the reasons why they gave it up.
The results, published this year in the journal European Psychiatry, pointed out that, of the 3.2% of the population who started treatment for depression, 56% stopped taking their medication during the first four months, and less than 25% of the cohort continued their treatment for more than 11 months
.
The researchers say patients are most likely to give up their medication during the acute stage of depression (the first months). "The levels to which they stick to their treatment also declines steeply between the first four and 12 months of the monitoring period", Serna points out.
"In our study, only 22% of patients completed their treatment", the expert explains. "The higher completion rates seen in chronic cases are in multiply-medicated patients, who are twice as likely as other patients to continue with their treatment for depression (31% vs. 15.3%).
Men are more likely to give up treatment
Meanwhile, men are more at risk of giving up their treatment earlier than women (50% of men gave up their medication after two months, while 50% of women gave it up after three months).
Depression is one of the commonest psychiatric diseases among adults, above all in industrialised countries. A European study carried out in 2004 found that almost 13% of individuals surveyed reported having a serious depressive illness at some point in their lives. This study revealed that in Spain, where anti-depressant use has risen in line with the availability of new drugs, 10.5% of the population suffers from depression.
Sources: Plataforma SINC, AlphaGalileo Foundation.
воскресенье, 3 июля 2011 г.
Antidepressants Improve Post-Stroke 'Thinking Outside The Box'
Antidepressant treatment appears to help stroke survivors with the kind of complex mental abilities often referred to as "thinking outside the box," according to a University of Iowa study.
The antidepressants' effects on study participants' abilities were independent of any changes in depression. In addition, the improvements in complex mental abilities were not seen immediately but during the course of 21 months after the treatment ended. The study results appear in the March 2007 issue of the British Journal of Psychiatry.
Antidepressant treatment already was known to improve mood in depressed post-stroke patients, but such therapy had not been examined on executive function in people with clinically diagnosed stroke, said Sergio Paradiso, M.D., Ph.D., the study's corresponding author and assistant professor of psychiatry at the UI Carver College of Medicine.
"We found that people diagnosed with stroke who often have a decline in 'executive function', that is, those mental abilities that enable us to respond appropriately to unfamiliar or complex situations, and support several cognitive, emotional and social capacities, showed improvement after receiving a 12-week treatment with antidepressants," Paradiso said.
Executive functions come into play, for instance, when we plan to take an alternative route home due to unexpected detours. This brain function involves stopping ingrained behavior, such as trying to take your usual route home. People with stroke often show impairments in executive function and may not be able to respond well to non-routine situations. This impairment may affect rehabilitation efforts.
The UI team included Kenji Narushima, M.D, Ph.D., UI resident physician in psychiatry, who contributed significantly to the study.
The study began with 47 patients who had had a stroke during the previous six months. These individuals were divided into three groups and randomly assigned (with the exception of those with certain medical conditions) to take the antidepressant fluoxetine (Prozac), the antidepressant nortriptyline (Aventyl or Pamelor) or a placebo (inactive substance).
Their executive functions were assessed using standard neuropsychological tasks at the end of 12 weeks of treatment, and again two years after the study had started. A total of 36 patients completed all the evaluations.
No significant differences were found between the antidepressant and placebo groups at the end of treatment. However, 21 months after the treatment ended, the placebo group showed continued worsening of the executive functions, whereas the group treated with antidepressants had clear and significant improvement, regardless of how their depressive symptoms changed.
"We were somewhat surprised to initially not find any difference after the first 12 weeks of treatment. It took another 21 months after the initial treatments for the antidepressants to have a detectable effect," Paradiso said.
The investigators hypothesize that antidepressants may foster recovery of neural tissue not directly destroyed by the stroke, yet because the process is slow, it takes months.
"Drugs such as antibiotics start working right away to kill germs. However, antidepressants may be reorganizing brain structure and re-establishing neuronal connections that were lost because of the death of neurons due to the stroke," Paradiso said. "We expect this regeneration to happen in longer, rather than brief, periods of time.
"We really appreciate the patients who made the commitment to participate in this two-year-long study while they were in their post-stroke recovery. The information we've learned will help us develop new studies," he added.
The researchers plan to examine individuals who responded favorably to the antidepressants and look noninvasively for brain changes.
"We can do functional and structural brain imaging studies using different technologies, including relatively new techniques that quantify chemicals in the brain," Paradiso said.
In addition to Paradiso and Narushima, the study involved UI researchers in psychiatry: David Moser, Ph.D., associate professor; Ricardo Jorge, M.D., assistant professor; and Robert G. Robinson, M.D., department head and the Paul W. Penningroth Professor of Psychiatry.
The study was supported in part by grants from the National Institute of Mental Health, part of the National Institutes of Health. Paradiso is additionally supported by the Edward J. Mallinckrodt Jr. Foundation and an NIH Institutional Career Development Award (K12).
STORY SOURCE: University of Iowa Health Science Relations, 5137 Westlawn, Iowa City, Iowa 52242-1178
Contact: Becky Soglin
University of Iowa
View drug information on Prozac Weekly.
The antidepressants' effects on study participants' abilities were independent of any changes in depression. In addition, the improvements in complex mental abilities were not seen immediately but during the course of 21 months after the treatment ended. The study results appear in the March 2007 issue of the British Journal of Psychiatry.
Antidepressant treatment already was known to improve mood in depressed post-stroke patients, but such therapy had not been examined on executive function in people with clinically diagnosed stroke, said Sergio Paradiso, M.D., Ph.D., the study's corresponding author and assistant professor of psychiatry at the UI Carver College of Medicine.
"We found that people diagnosed with stroke who often have a decline in 'executive function', that is, those mental abilities that enable us to respond appropriately to unfamiliar or complex situations, and support several cognitive, emotional and social capacities, showed improvement after receiving a 12-week treatment with antidepressants," Paradiso said.
Executive functions come into play, for instance, when we plan to take an alternative route home due to unexpected detours. This brain function involves stopping ingrained behavior, such as trying to take your usual route home. People with stroke often show impairments in executive function and may not be able to respond well to non-routine situations. This impairment may affect rehabilitation efforts.
The UI team included Kenji Narushima, M.D, Ph.D., UI resident physician in psychiatry, who contributed significantly to the study.
The study began with 47 patients who had had a stroke during the previous six months. These individuals were divided into three groups and randomly assigned (with the exception of those with certain medical conditions) to take the antidepressant fluoxetine (Prozac), the antidepressant nortriptyline (Aventyl or Pamelor) or a placebo (inactive substance).
Their executive functions were assessed using standard neuropsychological tasks at the end of 12 weeks of treatment, and again two years after the study had started. A total of 36 patients completed all the evaluations.
No significant differences were found between the antidepressant and placebo groups at the end of treatment. However, 21 months after the treatment ended, the placebo group showed continued worsening of the executive functions, whereas the group treated with antidepressants had clear and significant improvement, regardless of how their depressive symptoms changed.
"We were somewhat surprised to initially not find any difference after the first 12 weeks of treatment. It took another 21 months after the initial treatments for the antidepressants to have a detectable effect," Paradiso said.
The investigators hypothesize that antidepressants may foster recovery of neural tissue not directly destroyed by the stroke, yet because the process is slow, it takes months.
"Drugs such as antibiotics start working right away to kill germs. However, antidepressants may be reorganizing brain structure and re-establishing neuronal connections that were lost because of the death of neurons due to the stroke," Paradiso said. "We expect this regeneration to happen in longer, rather than brief, periods of time.
"We really appreciate the patients who made the commitment to participate in this two-year-long study while they were in their post-stroke recovery. The information we've learned will help us develop new studies," he added.
The researchers plan to examine individuals who responded favorably to the antidepressants and look noninvasively for brain changes.
"We can do functional and structural brain imaging studies using different technologies, including relatively new techniques that quantify chemicals in the brain," Paradiso said.
In addition to Paradiso and Narushima, the study involved UI researchers in psychiatry: David Moser, Ph.D., associate professor; Ricardo Jorge, M.D., assistant professor; and Robert G. Robinson, M.D., department head and the Paul W. Penningroth Professor of Psychiatry.
The study was supported in part by grants from the National Institute of Mental Health, part of the National Institutes of Health. Paradiso is additionally supported by the Edward J. Mallinckrodt Jr. Foundation and an NIH Institutional Career Development Award (K12).
STORY SOURCE: University of Iowa Health Science Relations, 5137 Westlawn, Iowa City, Iowa 52242-1178
Contact: Becky Soglin
University of Iowa
View drug information on Prozac Weekly.
пятница, 1 июля 2011 г.
African American Teen Mothers Likely To Have Another Baby If Depressed
In a recent article published in Archives of Pediatrics
& Adolescent Medicine, another pregnancy is likely -
within two years of having one child - for African American adolescent
mothers with symptoms of depression.
Author Beth Barnet, M.D (University of Maryland School of Medicine,
Baltimore) and colleagues build on previous research that has shown a
greater likelihood for teen mothers to experience depression compared
to adult mothers. Additionally, depression in African American teen
mothers is almost twice as likely as depression in white teen mothers.
A pregnancy occurring within 24 months after a birth is said to be a
rapid subsequent pregnancy, and it is quite common among young mothers.
The researchers note that "a recent meta-analysis found that 19 percent
of teen mothers experienced a subsequent pregnancy within 12 months and
38 percent experienced a subsequent pregnancy within 24 months. The
highest rates are among younger, economically disadvantaged African
American adolescents." It is known that parenting stress and negative
parenting behaviors - i.e., child abuse and neglect - are linked to
depression and subsequent pregnancy.
Researchers examined a sample of 269 teens between the ages of 12 and
18, most of whom were African American. All participants were
considered low-income and received prenatal care at five community
sites in Baltimore, MD. To assess depressive symptoms and measure the
occurrence of subsequent pregnancy, researchers administered
questionnaires to participants that were finished one or two years
after giving birth.
The results of the study are summarized below:
46% of the teens who completed at least one follow-up
questionnaire had depressive symptoms at the beginning of the
study.
49% (120 of 245) teens experienced a pregnancy within two
years of childbirth.
10% (28 of 245) had more than one subsequent
pregnancy.
The average time between pregnancies was about 11.4 months.
Teens with depressive symptoms were 44% more likely to have
a subsequent pregnancy.
The authors write that, "Teens having a subsequent pregnancy were more
likely to be school dropouts; not use condoms consistently at
follow-up; and report a relationship with their baby's father, who
tended to be older,"
"Depression is unhealthy for mothers and their children. Treating
maternal depression improves the health and well-being of both,"
conclude the authors. "Our findings do not tell us how depression might
fit into a casual pathway to repeat adolescent childbearing, but they
do suggest that depression may be an important malleable risk factor."
Since depression can be treated, the researchers also call for future
studies that should "evaluate whether improved recognition and
treatment of adolescent depression reduces the risk of rapid subsequent
pregnancy."
Double Jeopardy: Depressive Symptoms and Rapid Subsequent
Pregnancy in Adolescent Mothers
Beth Barnet; Jiexin Liu; Margo DeVoe
Archives of Pediatrics & Adolescent Medicine. (2008).
162(3):246-252.
Click
Here to View Abstract
Written by: Peter M Crosta
& Adolescent Medicine, another pregnancy is likely -
within two years of having one child - for African American adolescent
mothers with symptoms of depression.
Author Beth Barnet, M.D (University of Maryland School of Medicine,
Baltimore) and colleagues build on previous research that has shown a
greater likelihood for teen mothers to experience depression compared
to adult mothers. Additionally, depression in African American teen
mothers is almost twice as likely as depression in white teen mothers.
A pregnancy occurring within 24 months after a birth is said to be a
rapid subsequent pregnancy, and it is quite common among young mothers.
The researchers note that "a recent meta-analysis found that 19 percent
of teen mothers experienced a subsequent pregnancy within 12 months and
38 percent experienced a subsequent pregnancy within 24 months. The
highest rates are among younger, economically disadvantaged African
American adolescents." It is known that parenting stress and negative
parenting behaviors - i.e., child abuse and neglect - are linked to
depression and subsequent pregnancy.
Researchers examined a sample of 269 teens between the ages of 12 and
18, most of whom were African American. All participants were
considered low-income and received prenatal care at five community
sites in Baltimore, MD. To assess depressive symptoms and measure the
occurrence of subsequent pregnancy, researchers administered
questionnaires to participants that were finished one or two years
after giving birth.
The results of the study are summarized below:
46% of the teens who completed at least one follow-up
questionnaire had depressive symptoms at the beginning of the
study.
49% (120 of 245) teens experienced a pregnancy within two
years of childbirth.
10% (28 of 245) had more than one subsequent
pregnancy.
The average time between pregnancies was about 11.4 months.
Teens with depressive symptoms were 44% more likely to have
a subsequent pregnancy.
The authors write that, "Teens having a subsequent pregnancy were more
likely to be school dropouts; not use condoms consistently at
follow-up; and report a relationship with their baby's father, who
tended to be older,"
"Depression is unhealthy for mothers and their children. Treating
maternal depression improves the health and well-being of both,"
conclude the authors. "Our findings do not tell us how depression might
fit into a casual pathway to repeat adolescent childbearing, but they
do suggest that depression may be an important malleable risk factor."
Since depression can be treated, the researchers also call for future
studies that should "evaluate whether improved recognition and
treatment of adolescent depression reduces the risk of rapid subsequent
pregnancy."
Double Jeopardy: Depressive Symptoms and Rapid Subsequent
Pregnancy in Adolescent Mothers
Beth Barnet; Jiexin Liu; Margo DeVoe
Archives of Pediatrics & Adolescent Medicine. (2008).
162(3):246-252.
Click
Here to View Abstract
Written by: Peter M Crosta
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