четверг, 29 сентября 2011 г.

Stigma Surrounding Mental Illness Remains Despite Abundant Pharmaceutical Ads

The medicalization of such mental illnesses as depression and bipolar disorder, which have seen prescription drug advertisements on TV skyrocket since such advertising became permissible in 1997, has done nothing to remove the harmful stigma attached to the illnesses, according to sociologists from Indiana University and the University of North Carolina in Chapel Hill.



"The findings fly in the face of current thinking about ways that stigma can be reduced," said Peggy Thoits, Virginia L. Roberts Professor of Sociology in IU's College of Arts and Sciences.



Stigma has posed a steadfast obstacle to the treatment of many mental health illnesses. Negative perceptions of mental illness color the support and advice people get from their friends, family and even their physicians and can create a reluctance to seek help.



The study by Thoits and lead author Andrew R. Payton, graduate student at University of North Carolina in Chapel Hill, sought to see if attitudes toward mental illness have changed since the U.S. Food and Drug Administration issued new guidelines allowing pharmaceutical companies to air TV ads.



Theoretically, when a condition such as depression comes to be viewed as a treatable medical condition instead of a moral failing or spiritual condition, this should reduce the blame and stigma attached to depression. The researchers examined the Mental Health Modules in the General Social Survey during these intervening years and saw no change in attitudes toward people with mental illness, specifically when they compared depression, which was a focus of many TV commercials, to schizophrenia, for which no drugs have been advertised.



"We're making a big assumption, that marketing drugs to treat some these conditions is actually penetrating the consciousness of viewers, giving them the ability to recognize symptoms and conceptualize them as disorders and to see that these disorders can be relieved essentially with drugs," Thoits said.



The study was presented in the session Medical Institutions and Mental Health at the American Sociological Association meeting.


понедельник, 26 сентября 2011 г.

Targeting Depression Can Help Diabetes Patients Improve Overall Health

Frequently, depression and diabetes go hand in hand. And depression can be a major obstacle for people living with diabetes, making it less likely they'll stick to a medicine schedule or exercise regimen.


A team of researchers led by investigators at the VA Ann Arbor Healthcare System and the University of Michigan Health System worked to improve diabetes patients' health by first addressing their depression. The study evaluated a year-long program that began with behavioral therapy sessions over the telephone with a specially trained nurse and later phased in a walking program.


Their findings, published online ahead of print in Medical Care, showed the intervention was successful in lowering patients' blood pressure, increasing their physical activity by about four miles of walking per week and easing their depressive symptoms.


"Depression is a common, treatable issue for many people who have diabetes," says study lead author John Piette, Ph.D., a senior research scientist at the VA and professor of internal medicine at the U-M Medical School. "Unfortunately, most busy clinics cannot provide the level of intensive care these patients need. This study shows that telephone-delivered counseling can improve patients' access to effective depression care, improve their cardiovascular health and get them moving again."


The cognitive behavior therapy helped the study participants address negative thought processes and behaviors that made it difficult for them to manage their diabetes and make healthy lifestyle choices, Piette says.


The physical activity component of the program used pedometers to help patients set walking goals and monitor their progress. Along with physical benefits, exercise also helps boost one's mood.


Most patients entered the study with relatively good blood glucose control. So while the intervention did not lead to a drop in A1C, a common measurement of blood glucose levels, patients did see more than a 4-point improvement in their systolic blood pressure, walked about half a mile more per day and reported an improvement in their general quality of life.


At the end of the year, 58 percent of patients who received the intervention had depression symptoms that were in remission, compared to only 39 percent of the patients who did not receive counseling.


"Health systems should consider routinely offering structured telephone psychotherapy to their patients with diabetes and depression," says senior study author Marcia Valenstein, M.D., M.S., an associate professor of psychiatry at the U-M Medical School and VA research scientist. "Patients with depression and additional chronic medical conditions do better if their depression is addressed first, if it is addressed systematically, and if exercise is also encouraged. Delivering therapy by telephone makes it feasible to reach large numbers of patients who may not attend traditional in-person appointments."


Methods: 291 patients with type 2 diabetes and significant depressive symptoms completed the study; 145 received the intervention, which consisted of 12 weeks of cognitive behavioral therapy over the phone, followed by nine monthly "booster" sessions. After six weeks, a pedometer-based walking program was introduced. Depression, coping and quality-of-life measurements were taken using standardized scales.


Funding: The research was funded by grants from the National Institutes of Health, Michigan Diabetes Research and Training Center and the Michigan Institute for Clinical and Health Research.


Additional authors: Caroline Richardson, M.D., of U-M and VA; Sonia Duffy, Ph.D., of U-M and VA; Joseph Himle, Ph.D., of U-M; and Trissa Torres, M.D.; Mark Vogel, Ph.D.; and Kimberly Barber, Ph.D., all of Genesys Health System, Flint, Mich.


Citation: "A Randomized Trial of Telephonic Counseling Plus Walking for Depressed Diabetes Patients," Medical Care. doi: 10.1097/MLR.0b013e318215d0c9


пятница, 23 сентября 2011 г.

Research Investigates Whether Vitamin Folate Helps To Treat Depression

New research commissioned by the NIHR Health Technology Assessment (HTA)
programme is looking into whether the vitamin folate can help in the
treatment of depression. One in five people experience depression during
their lives and only half of these people respond to antidepressant
treatment.



Folate, a vitamin found in foods such as green vegetables, helps to
produce chemicals that regulate brain functions, including mood, sleep
and appetite. A Cochrane review concluded that folate may have a role as
a supplement to other treatments for depression, but the evidence is
limited and primary research is needed to test this.



"Antidepressants work by improving the way certain chemical messengers
work in the brain and folate helps produce the chemicals needed for this
process," says Professor Ian Russell of the University of Wales Bangor.



"Low levels of folate from a poor diet or similar factors could worsen
depression and stop antidepressants from working optimally."



Researchers in Wales led by Professor Russell are set to conduct the
biggest randomised controlled trial of its kind to test whether a folate
tablet taken daily by people with depression will help their
antidepressants to work better. In addition to their antidepressants,
participants will be given either a folate tablet or a dummy tablet for
three months. Researchers will ask them about the effect this has on
their depression, and take blood samples to corroborate this.



"We welcome this research initiative into the potential of folate to
enhance the effect of anti-depressant medication," says Lindsay Foyster,
Director of Mind Cymru. "If the research proves folate to be efficacious
then an easily acquired simple supplement or an informed improvement in
diet could make a significant contribution to the self management of
depression."



For more information visit: hta.ac.uk/project.asp?PjtId=1537








Notes:



1. The HTA programme produces high quality research information
about the effectiveness, costs, and broader impact of health
technologies for those who use, manage and provide care in the NHS. This
is a programme of the National Institute for Health Research
(nihr.ac.uk) and is the largest and longest running of the national
programmes with 340 projects published since its inception in 1993.
About 50 are published each year, all available for download free of
charge from the website. It is coordinated by the National Coordinating
Centre for Health Technology Assessment (NCCHTA), based at the
University of Southampton.



Visit hta.ac.uk for more information.



2. Mind (National Association for Mental Health) is the leading
mental health charity in England and Wales and works to create a better
life for everyone with experience of mental distress.



Visit mind.uk for more information.



For further information please go to:
National Institute for Health Research And
University of Southampton

вторник, 20 сентября 2011 г.

Omega-3 Fatty Acids Affect Risk Of Depression, Inflammation

A new study suggests that people whose diets contain dramatically more of one kind of polyunsaturated fatty acid than another may be at greater risk for both clinical depression and certain inflammatory diseases.


The report, published online this week in the journal Psychosomatic Medicine, suggests that we need to balance out our intake of omega-6 and omega-3 fatty acids. The current typical American diet contains 20 times more omega-6 than omega-3, a ratio that researchers say should be lowered to 4-to-1, or even 2-to-1.


This is the most recent in a long series of experiments Ohio State University researchers have conducted on the links between psychological stress and immunity. The addition of dietary questions to studies that have previously focused solely on emotional and biochemical markers may yield important new clues about the immune system.


"In this study, we're looking at the intersection of behavior, immune function and diet. In past experiments, we concentrated only on the first two," explained Jan Kiecolt-Glaser, professor of psychiatry and psychology at Ohio State and lead author on the paper.


"It now appears that diet is a very important variable in the equation as to how people respond to depression and stress."


The study, conducted in OSU's Institute for Behavioral Medicine Research, focused on a group of 43 middle-aged to elderly men and women, nearly half of which were the caregiver spouses of people with Alzheimer's or other dementias. By including caregivers who typically report greater stress and more depression than similar adults who are not caregiving, the researchers could look at how depression and diet might interact to affect inflammation.


Blood samples were drawn from each person in the study and tested for interleukin-6 (IL-6), tumor necrosis factor -alpha (TNF-alpha ) and the receptor molecule for IL-6. Participants also completed a survey questionnaire that gauged their level of depression.


The analysis showed that participants who had much more omega-6 -- compared to omega-3 -- fatty acids, and who also were reporting more symptoms of depression, had much higher levels of IL-6 and TNF-alpha, two cytokines which enhance inflammation.


"The data suggest that higher depression and a poorer diet in terms of omega-3 can work together to promote inflammation. Other researchers have shown that clinically depressed people -- those with more severe depression -- often have lower omega-3 levels in their blood, and several studies have shown that supplementing diets with omega-3 improves depression," Kiecolt-Glaser said, although the reason isn't clear.


"People who are depressed don't eat well, or it might be that there is something about depression that affects how well people process such foods."















In recent years, research has shown that an increase in omega-3 fatty acids in the diet has specific health benefits, especially in patients with depression, cardiovascular disease and inflammatory and autoimmune diseases.


Martha Belury, an associate professor of human nutrition, endocrinology, diabetes & metabolism at Ohio State and co-author of the study, said the design of the study was important.


"We looked at people who were experiencing real depression, not those whose depression arose as a part of some experiment, and we could clearly see a relationship between lower omega-3 fatty acids and certain markers of depression and inflammation."


Belury said that current recommendations allow up to two servings each week of cold-water fish the best source of omega-3 such as salmon or trout. This would not apply to pregnant women, she said, where concerns are greater about the heavy metal contamination such fish might contain. Omega-3 is also available as nutritional supplements


"This study has shown that even in people who did not take supplements, maybe just a little bit more omega-3, could help reduce their markers for both stress and depression," Belury said.


"The important message for consumers is that they don't have to take mega-doses of omega-3 to have some impact. It might not take a whole lot to have a significant clinical impact," Belury said.


The researchers are now starting a larger, more comprehensive randomized and controlled trial of omega-3 in adults between the ages of 50 and 80 in hopes of testing the questions raised in this pilot study.


Ron Glaser, professor of internal medicine, molecular virology, immunology and medical genetics; David Beversdorf, an assistant professor of neurology; Stanley Lemeshow, dean of the College of Public Health, and Kyle Porter, a statistician in the Center for Biostatistics, were also part of the project. The research was supported in part by the National Institutes of Health.


Ohio State University

1125 Kinnear Rd.

Columbus, OH 43212-1153

United States

osu/

суббота, 17 сентября 2011 г.

Study links brain fatty acid levels to depression

A group of researchers from Israel has discovered that rats exhibiting the signs of depression have increased levels of
the omega-6 fatty acid, arachidonic acid, in their brains. The details of their findings appear in the June issue of the
Journal of Lipid Research, an American Society for Biochemistry and Molecular Biology journal.


During recent years, omega-3 fatty acids have enjoyed increased popularity as numerous studies have shown that supplementing
diets with fish oil (a natural source of this polyunsaturated fatty acid) does everything from reducing the risk of heart
disease to preventing arthritis. There is also evidence that depression may be associated with a dietary deficiency in
omega-3 fatty acids. This "phospholipid hypothesis" of depression has been supported by research showing that omega-3 fatty
acid concentration in the blood of depressed patients is lower than that in control patients.


"The "phospholipid hypothesis" of depression postulates that decreased omega-3 fatty acid intake, and hence, perhaps
decreased brain omega-3 fatty acid content, could be responsible for the disease," explains Dr. Pnina Green of Tel Aviv
University. "In humans, because of high dietary variability and the obvious inability to examine brain tissue, the theory is
backed up mainly by indirect evidence. The availability of the Flinders Sensitive Line rat, an animal model of depression,
overcomes both these obstacles."


In the Journal of Lipid Research study, Dr. Green in collaboration with Dr Gal Yadid of Bar-Ilan University, Ramat Gan, used
the Flinders Sensitive Line rats to investigate the link between omega-3 fatty acids and depression. They examined the brains
of the depressed rats and compared them with brains from normal rats. Surprisingly, they found that the main difference
between the two types of rats was in omega-6 fatty acid levels and not omega-3 fatty acid levels. Specifically, they
discovered that brains from rats with depression had higher concentrations of arachidonic acid, a long-chain unsaturated
metabolite of omega-6 fatty acid.


Arachidonic acid is found throughout the body and is essential for the proper functioning of almost every body organ,
including the brain. It serves a wide variety of purposes, from being a purely structural element in phospholipids to being
involved in signal transduction and being a substrate for a host of derivatives involved in second messenger function.



"The finding that in the depressive rats the omega-3 fatty acid levels were not decreased, but arachidonic acid was
substantially increased as compared to controls is somewhat unexpected," admits Dr. Green. "But the finding lends itself
nicely to the theory that increased omega-3 fatty acid intake may shift the balance between the two fatty acid families in
the brain, since it has been demonstrated in animal studies that increased omega-3 fatty acid intake may result in decreased
brain arachidonic acid."


Although far less attention has been paid to dietary requirements for omega-6 fatty acids, which can be found in most edible
oils and meat, perhaps in the future depression may be controlled by increasing omega-3 fatty acid intake and decreasing
omega-6 fatty acid intake.


The American Society for Biochemistry and Molecular Biology (ASBMB) is a nonprofit scientific and educational organization
with over 11,000 members in the United States and internationally. Most members teach and conduct research at colleges and
universities. Others conduct research in various government laboratories, nonprofit research institutions, and industry.



Founded in 1906, the Society is based in Bethesda, Maryland, on the campus of the Federation of American Societies for
Experimental Biology. The Society's primary purpose is to advance the sciences of biochemistry and molecular biology through
its publications, the Journal of Biological Chemistry, the Journal of Lipid Research, Molecular and Cellular Proteomics, and
Biochemistry and Molecular Biology Education, and the holding of scientific meetings.


For more information about ASBMB, see the Society's website at asbmb.


The manuscript for the Journal of Lipid Research paper can be downloaded from the following URL: jlr/cgi/content/abstract/C500003-JLR200v1.


Contact: Nicole Kresge

nkresgeasbmb

301-634-7415

American Society for Biochemistry and Molecular Biology

asbmb

среда, 14 сентября 2011 г.

The Damaging Effects Of Discrimination

It's tough being a teen. Are you in or are you out? Are you hanging with the right crowd? Are you dressing and talking and acting the right way? For adolescents who are ethnic minorities, on top of this quest to "fit in" is the added layer - and the burden - of dealing with discrimination, say UCLA researchers.



In a new study, the researchers found that adolescents from Latin American and Asian backgrounds experienced more discrimination than their peers from European backgrounds and that the discrimination came not only from other adolescents but from adults as well. The level of discrimination also impacted these teens' grade-point averages and their health and was associated with depression, distress and lower levels of self-esteem.



The findings appear in the current online edition of the Journal of Research on Adolescence.



For the study, lead author Virginia W. Huynh, a graduate student in the laboratory of Andrew J. Fuligni, a professor of psychiatry at the Semel Institute for Neuroscience and Human Behavior at UCLA, recruited 601 high school seniors, equally divided between males and females, and asked them to maintain a daily diary for two weeks to record any discriminatory events or comments they experienced. They were also asked to separately record on a four-point scale any physical symptoms, such as headaches, stomachaches or general pain.



Among the teens in the study, nearly 60 percent reported experiencing discrimination from other teens, and 63 percent reported discrimination from adults; 12 percent reported experiencing discrimination on a daily basis. Adolescents from Latin American backgrounds reported more adult discrimination than Asian Americans, who, in turn, reported more adult discrimination than teens from European backgrounds. Latin American and Asian American teens also reported higher levels of discrimination by their peers.



The researchers found that teens who reported higher levels of peer or adult discrimination also reported more aches, pains and other symptoms, as well as a lower overall grade-point average. Thus, discrimination may not only tax adolescents' physical and psychological resources but may also affect their ability to achieve in school, the researchers said.



Although seniors in high school are close to adults in terms of their cognitive capacities and their ability to recognize discrimination when they see or experience it, they are also distinct from adults, said Fuligni, the study's senior author.



"These are the years when social identity is arguably more salient among teenagers who are struggling with defining who they are," he said. "Adding on a 'layer' of discrimination is not an easy thing for them to deal with."



By comparing the amount of discrimination the students experienced with their ratings of their physical well-being and their grades at the conclusion of the semester, the researchers were able to examine the relationship between discrimination and health among the adolescents.



The study furthers the understanding of the normal development of ethnic minority and immigrant adolescents, the researchers say, because it shows that adult and peer discrimination may have implications for adolescents' physical health.



"Discrimination significantly predicted lower GPAs, higher levels of depression, higher levels of distress, lower self-esteem and more physical complaints," Fuligni said. "So the bottom line? Discrimination is harmful."



Funding for the study was provided by a grant from the Russell Sage Foundation. The authors report no conflict of interest.


воскресенье, 11 сентября 2011 г.

INVEGA® (Paliperidone ER) Approved As First Antipsychotic Treatment For Schizoaffective Disorder In The EU

Janssen-Cilag International NV has received approval from the European Commission for the first antipsychotic treatment for schizoaffective disorder. INVEGA® (paliperidone ER) is now indicated for the treatment of psychotic or manic symptoms of schizoaffective disorder. Effect on depressive symptoms has not been demonstrated.



The decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency. The CHMP concluded that the new therapeutic indication for INVEGA® brings significant clinical benefit in comparison with existing therapies.



Schizoaffective disorder is a chronic and disabling mental illness, characterised by both symptoms of schizophrenia and a major mood disorder, such as bipolar disorder or depression.Patients may experience the clinical symptoms of schizophrenia, such as hallucinations or delusions, as well as symptoms of mania and/or depression. Schizoaffective disorder is thought to be one-third as common as schizophrenia, with an estimated prevalence of approximately 1 in every 300 people1. Schizoaffective disorder may also account for up to one-quarter of admissions to inpatient mental health facilities2.



"Janssen is committed to helping improve the lives of people with serious mental illness and has a long history of developing innovative medicines in this field," said Dr Christophe Tessier*, Medical Affairs Director, Psychiatry, Janssen. "We are proud to be able to bring to market the first antipsychotic treatment for schizoaffective disorder in Europe - a difficult to diagnose condition associated with a high rate of hospitalisations and suicidal behaviour."



The approval is based on two international, randomised, double-blind, placebo-controlled 6-week studies in patients diagnosed with schizoaffective disorder3,4. In the first six-week study, patients (n=316) received one of two daily doses of INVEGA®: 6 mg with the option to reduce to 3 mg, or 12 mg with the option to reduce to 9 mg, or placebo3. In the second study, patients (n=311) were randomised to flexible doses of INVEGA® (3-12 mg once daily) either as monotherapy or in addition to treatment with mood stabilisers and/or antidepressants or placebo4.
















Efficacy was evaluated by the change in patients' symptoms after six weeks as measured by the positive and negative syndrome scale (PANSS). The results for INVEGA® in both studies were superior to placebo. In the first study, patients receiving the higher dose of INVEGA® had a significant decrease in their symptom score compared with those receiving placebo (-32.4 compared with -24.1, p=0.003)3. The lower dose of INVEGA® was not significantly different from placebo (p=0.187). In the second study, the mean decrease in symptom score was -20.0 in the INVEGA® group and -10.8 in the placebo group 3 (p=0.0001)4. Furthermore, among patients with prominent manic symptoms as measured by the Young Mania Rating Scale (YMRS baseline score ?‰?16) INVEGA® resulted in significant improvements in manic symptomatology compared to placebo.



"These two studies combined represent the largest set of prospective data in patients with schizoaffective disorder and provide important insights into this understudied disease", said Dr Carla M. Canuso**, Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ and lead investigator of the two studies. "INVEGA®was proven to be effective both as a monotherapy and as an adjunctive therapy in reducing psychotic and manic symptoms and provides a welcome treatment option for this debilitating condition."



About schizoaffective disorder



Schizoaffective disorder usually develops in early adulthood and is more common in women. It can affect all aspects of a person's daily life, including work, personal relationships and the ability to take care of oneself. Patients with schizoaffective disorder have a high rate of hospitalisations and a higher rate of co-morbid substance abuse than patients with schizophrenia5,6. In addition, patients with schizoaffective disorder appear to be at greater risk of suicidal behaviour than patients with schizophrenia and mood disorders5,6.



About INVEGA® (paliperidone ER)



INVEGA® (paliperidone ER), an atypical antipsychotic medication, was first approved in Europe in June 2007 for the treatment of schizophrenia. INVEGA® is a novel molecule (paliperidone) delivered via an osmotic drug delivery system (OROS®) which provides a steady, smooth release of medication over 24 hours. This reduces the peaks and troughs in drug plasma levels associated with immediate release oral formulations and leads to a low potential for increased side effects as well as ensuring consistent efficacy. INVEGA® is the first antipsychotic medication to have significantly improved personal and social performance recognised in its Summary of Product Characteristics (SPC). Further information about INVEGA® can be found here.



References:


1. Perela J et al. Lifetime Prevalence of Psychotic and Bipolar I Disorders in a General Population. Arch Gen Psychiatry. 2007;64, 19 - 28.


2. Kent S, Fogarty M, Yellowlees, P. (1995). Heavy Utilization of Inpatient and Outpatient Services in a Public Mental Health Service. Psychiatr Serv. 1995;46, 12, 1254 - 1257.


3. Canuso C et al. A Randomized, Double-Blind, Placebo-Controlled Study of 2 Dose Ranges of Paliperidone Extended-Release in the Treatment of Subjects With Schizoaffective Disorder. J Clin Psychiatry. 2010;71, 5, 587 - 598.


4. Canuso C et al. Paliperidone Extended-Release in Schizoaffective Disorder: A Randomized, Controlled Study Comparing a Flexible Dose With Placebo in Patients Treated With and Without Antidepressants and/or Mood Stabilizers. J Clin Psychopharmacology. 2010;30, 5, 487 - 495.


5. Cheniaux E, Landeira-Fernandez J, Lessa Telles L, et al. Does schizoaffective
disorder really exist? A systematic review of the studies that compared schizoaffective disorder with schizophrenia or mood disorders. J Affect Disord. 2008;106, 3, 209-217.


6. Potkin SG, Alphs L, Hsu C, et al. InterSePT Study Group. Predicting suicidal risk in schizophrenic and schizoaffective patients in a prospective two-year trial. Biol Psychiatry. 2003;54, 4, 444-452.



* Dr Christophe Tessier is a full time employee of Janssen, EMEA


** Dr Carla M. Canuso is a full time employee of Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ


четверг, 8 сентября 2011 г.

Use Of Antidepressants In Young Adults Linked To Higher Risk Of Suicidal Behavior

Research published today on bmj reports that adults taking antidepressants are not at greater risk of suicidal thoughts or behavior. On the other hand, young adults less than 25 years of age are at an increased risk, comparable to that seen in children and adolescents.


The article elaborates on data previously made available by the US Food and Drug Administration (FDA) two years ago. It incorporates different methods, supplementary examinations of the data, and discusses at length the implications of the findings.


There is confirmation in earlier studies that antidepressant drugs are associated with an increased risk of suicidal behavior and feelings in children and adolescents. This is mostly evident in the early stages of treatment. This prompted the FDA to include a black box warning to antidepressants in 2005 and to examine trials of antidepressants in adults to search for comparable effects.


Dr Marc Stone and his collaborators from the FDA studied data on suicidal thinking and behavior from published and unpublished randomized trials on antidepressants in adults. The information was provided by eight manufacturers of antidepressant products. Records from 372 placebo controlled trials involving nearly 100,000 patients were reviewed.


The results revealed eight committed suicides, 134 suicide attempts, 10 patients who had made planning without attempting suicide, and 378 patients who had thoughts about suicide but had not acted on them.


In general, there was no distinction in drug type and diagnostic category and the effect on risk of suicidal behavior. However, there were some differences among selective serotonin reuptake inhibitors (SSRIs).


On the other hand, an increased risk was noted among adults under 25 years of age, comparable to that reported in children and adults. This amplified risk was highest in young patients with psychiatric disorders other than depression.


The authors explain: "These results suggest that, compared with placebo, the risks of suicidality associated with antidepressants are strongly age dependent - the risk is raised in people under 25, not affected in those aged 25-64, and reduced in those aged 65 and older."


The findings also sustain the suggestion that antidepressant drugs can have two different effects:


??? Adverse effect in some patients that promotes suicidal thoughts or behavior, with a risk that appears to weaken with age.

??? Protective effect in others that alleviates depression and reduces any suicidal risk.


The authors call for further research, particularly in terms of possible mechanisms for age related differences.


Meanwhile, the FDA has extended the suicide warning on antidepressant drugs with this new information, including the significant relation of the findings with age.


In an associated editorial Professor John Geddes from the University of Oxford and collaborators caution that "fundamental uncertainty" persists. They call attention to essential restrictions in the analysis, such as the very low numbers of completed suicides in the primary trials and a lack of precision in some of the methods used. In addition, they consider some significant differences in risk between individual drugs.


They add: "It is becoming apparent that antidepressants vary in both their efficacy and adverse effects." In closing they say: "The increased risk of suicidal behavior in adults taking antidepressants is probably restricted to younger people and varies greatly between individual drugs."



"Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration"

Marc Stone, medical officer, Thomas Laughren, director, division of psychiatry products, M Lisa Jones, medical officer, Mark Levenson, mathematical statistician, P Chris Holland, mathematical statistician, Alice Hughes, associate director for safety, division of neurology products, Tarek A Hammad, associate director, division of epidemiology, Robert Temple, associate director for medical policy, George Rochester, mathematical statistics team leader

BMJ 2009; 339:b2880


"Risk of suicidal behaviour in adults taking antidepressants"

John Richard Geddes,professor of epidemiological psychiatry, Corrado Barbui, lecturer in psychiatry, Andrea Cipriani, lecturer in psychiatry

doi=10.1136/bmj.b3066

bmj


Written by Stephanie Brunner (B.A.)



понедельник, 5 сентября 2011 г.

Impax Laboratories Receives Tentative FDA Approval For Generic Cymbalta(R) Delayed-Release 20, 30 And 60 Mg Capsules

Impax Laboratories, Inc. (NASDAQ: IPXL) confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application for generic version of Cymbalta® delayed-release (duloxetine hydrochloride) 20, 30 and 60 mg capsules. Eli Lilly and Company markets Cymbalta®, a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia.


According to Wolters Kluwer Health, U.S. sales of Cymbalta® capsules were approximately $3.0 billion for the 12 months ended September 30, 2010.


пятница, 2 сентября 2011 г.

Antidepressants Double Risk Of Bone Fracture

A Canadian study suggests that people over 50 on a certain type of antidepressant are twice as likely to suffer bone fractures.


The study is published in the Archives of Internal Medicine.


The research was conducted by a team of scientists from various Canadian research centres.


They looked at data from a group of patients of average age 65.1 who were aged 50 and over who were taking SSRI antidepressants on a daily basis. These
patients were part of a larger study under the umbrella of the Canadian Multicentre Osteoporosis Study (CaMos) Research Group. The CaMos group comprises a
randomly selected, population-based cohort of 5008 adults aged 50 and over who are followed over 5 years for incident fractures.


The patients had been filling in questionnaires about their bone breakages cause by various minor events such as falling out of bed, off a chair, or similar minimal trauma incidents. All the fractures had been confirmed with radiographs.


The researchers found 137 patients within the CaMos cohort who were using SSRIs on a daily basis. The SSRIs they were using included: fluvoxamine (brand name uvox),
citalopram (Celexa), fluoxetine (Prozac), sertraline (Zoloft) and paroxetine (Paxil). These were the ones that were on the market at the start of
the CaMos study.


After correlating the data from the bone fractures with the data on the SSRI intake, the results showed that taking SSRI antidepressants every day doubled the risk of "clinical fragility fracture" in adults aged 50 and over, even after
taking into account various other factors such as age, hip bone mineral density, and estrogen levels.


The also found a dosage effect, where a 1.5 increase in risk of bone fracture was linked to a doubling of daily dose of SSRI.


Since fragility fractures are already common in the over 50s, this additional risk could have significant health consequences for them.


The motive for the study came from knowing that fragility fractures and depression are not uncommon in the over 50s, and SSRIs are a commonly prescribed
medication for depression in this age group. But the researchers were not aware of any studies that had tried to link the two together.


The researchers suggest that doctors should take into account the risk of fragility fracture when they prescribe SSRI antidepressants to patients in this age
group.


Selective serotonin reuptake inhibitors (SSRIs) are antidepressants used to treat anxiety and personality disorders and depression. They increase the level
of serotonin in the brain by stopping it being reabsorbed by the presynpatic cell, which leaves more of it around to produce its mood-altering effects.


"Effect of Selective Serotonin Reuptake Inhibitors on the Risk of Fracture."

J. Brent Richards, Alexandra Papaioannou, Jonathan D. Adachi, Lawrence Joseph, Heather E. Whitson, Jerilynn C. Prior, David Goltzman.

Arch Intern Med. 2007;167:188-194.


Click here for Abstract (no subscription required).








View drug information on Celexa; Paxil CR; Prozac Weekly.