Use of drugs such as Abilify, Seroquel and Zyprexa for treatment-resistant depression is gaining ground. Some see an 'unmet need' for medication. Others worry about side effects.
About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify "might be right for them." Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery.
Leuchter wondered what was up: Depressed patients didn't usually seek out drugs used to quell psychiatry's most disturbing symptoms.
What was up, he soon discovered, was spending on a new advertising campaign touting Abilify as an "add-on" treatment for depression. For the first time since the arrival of a new generation of antipsychotic medications -- six drugs called the "atypicals" because they work differently from the earlier generation of antipsychotic drugs -- the makers of one, Abilify, had been granted the legal right to market to a vast new population of patients beyond those with schizophrenia or bipolar disorder.
This week, a Food and Drug Administration advisory panel recommended that the agency should grant the makers of a second atypical antipsychotic drug -- Seroquel XR -- similar latitude. The drug giant AstraZeneca wants permission to market the drug as a treatment for depression or anxiety that has not yielded to antidepressants alone.
READ MORE @ LOS ANGELES TIMES
Sunday, April 12, 2009
Saturday, April 11, 2009
When to Avoid Antidepressants in Bipolar Patients
Patients with bipolar depression who exhibit even minimal manic symptoms are at heightened risk for switching into mania if they receive antidepressant medication, according to a new report from the Bipolar Collaborative Network.1
This finding from the multinational sites of the former Stanley Foundation Bipolar Network emerged in a post hoc analysis of 176 patients who participated in a 10-week controlled trial of adjunctive antidepressant medication for bipolar I or II depression. The investigators sought to identify clinical correlates for the development of treatment-emergent affective switching from patient demographics and baseline symptoms.
Possible risk factors for affective switch, which have been previously suggested, include comorbid substance abuse, younger age, decreased thyroid-stimulating hormone, and rapid cycling. Although none of these factors were predictive in this study, the investigators acknowledged that their modest effect size precluded ruling these out in other populations. They characterize this study, however, as the first controlled assessment of antidepressant treatment in bipolar depression to correlate a specific phenomenological presentation at baseline with affective switching in subsequent antidepressant treatment.
READ MORE @ PSYCHIATRIC TIMES
This finding from the multinational sites of the former Stanley Foundation Bipolar Network emerged in a post hoc analysis of 176 patients who participated in a 10-week controlled trial of adjunctive antidepressant medication for bipolar I or II depression. The investigators sought to identify clinical correlates for the development of treatment-emergent affective switching from patient demographics and baseline symptoms.
Possible risk factors for affective switch, which have been previously suggested, include comorbid substance abuse, younger age, decreased thyroid-stimulating hormone, and rapid cycling. Although none of these factors were predictive in this study, the investigators acknowledged that their modest effect size precluded ruling these out in other populations. They characterize this study, however, as the first controlled assessment of antidepressant treatment in bipolar depression to correlate a specific phenomenological presentation at baseline with affective switching in subsequent antidepressant treatment.
READ MORE @ PSYCHIATRIC TIMES
Friday, April 10, 2009
FDA Approves Pioneering Treatment for Obsessive- Compulsive Disorder
Psychiatrists will have to take the lead in ensuring that deep-brain stimulation (DBS)—approved by the FDA in February for the first time for use in obsessive-compulsive disorder (OCD)—is used appropriately.
Medtronic Inc’s Reclaim DBS therapy was approved under a humanitarian device exemption, which means that the system will be used on a relatively small number of adults (no more than 4000 and probably considerably fewer) with recalcitrant OCD.
The DBS device offers an adjustable, reversible, and nondrug therapy. This surgically implanted device- similar to a pacemaker- delivers carefully controlled electrical pulses to precisely targeted areas of the brain.
Only one other medical device has been approved for treatment of a psychiatric condition: the vagus nerve stimulation (VNS) implantation device made by Cyberonics. In 1997, the FDA approved the use of VNS as an adjunctive therapy for partialonset epilepsy; in 2005, its use in treatment-resistant depression was also approved. But Benjamin D. Greenberg, MD, PhD, told Psychiatric Times that VNS has been somewhat controversial, and insurance reimbursement remains an issue. Greenberg, who is associate professor of psychiatry at Brown University Medical School in Providence, RI, noted, however, that VNS does not involve brain surgery, as DBS does. Thus, the potential adverse effects from DBS, while relatively rare, can be more serious.
READ MORE @ PSYCHIATRIC TIMES
Medtronic Inc’s Reclaim DBS therapy was approved under a humanitarian device exemption, which means that the system will be used on a relatively small number of adults (no more than 4000 and probably considerably fewer) with recalcitrant OCD.
The DBS device offers an adjustable, reversible, and nondrug therapy. This surgically implanted device- similar to a pacemaker- delivers carefully controlled electrical pulses to precisely targeted areas of the brain.
Only one other medical device has been approved for treatment of a psychiatric condition: the vagus nerve stimulation (VNS) implantation device made by Cyberonics. In 1997, the FDA approved the use of VNS as an adjunctive therapy for partialonset epilepsy; in 2005, its use in treatment-resistant depression was also approved. But Benjamin D. Greenberg, MD, PhD, told Psychiatric Times that VNS has been somewhat controversial, and insurance reimbursement remains an issue. Greenberg, who is associate professor of psychiatry at Brown University Medical School in Providence, RI, noted, however, that VNS does not involve brain surgery, as DBS does. Thus, the potential adverse effects from DBS, while relatively rare, can be more serious.
READ MORE @ PSYCHIATRIC TIMES
Wednesday, April 8, 2009
FDA Review Questions Cardiac, Suicide Risks for Investigational Antipsychotic
Investigational antipsychotic drug sertindole (Serdolect) is effective at treating schizophrenia, but it may lead to sudden cardiac death, according to an FDA review.
The agency released its review in advance of Tuesday's meeting of the Psychopharmacologic Drugs Advisory Committee, which will decide if the drug's cardiovascular risk is an obstacle to FDA approval.
The advisory panel will also consider the sponsor's suicide prevention claim, and whether to recommend to the FDA that the drug is safe and effective. The vote will effectively amount to a recommendation of approval or denial.
Sertindole is already used in other countries to treat schizophrenia.
According to the FDA review, led by psychiatrist Phillip Kronstein, M.D., sertindole is effective in treating schizophrenia, but concerns remain about the drug's potential to prolong the heart's QT interval, which can lead to sudden cardiac death. That same cardiac risk has been seen in other antipsychotic drugs similar to sertindole.
Sertindole is a so-called atypical antipsychotic drug, Its specific mechanism appears to be to inhibit spontaneously active dopamine neurons in the mesolimbic ventral tegmental area without affecting dopamine neurons in the substantial nigra compacta.
READ MORE @ MADPAGE TODAY
The agency released its review in advance of Tuesday's meeting of the Psychopharmacologic Drugs Advisory Committee, which will decide if the drug's cardiovascular risk is an obstacle to FDA approval.
The advisory panel will also consider the sponsor's suicide prevention claim, and whether to recommend to the FDA that the drug is safe and effective. The vote will effectively amount to a recommendation of approval or denial.
Sertindole is already used in other countries to treat schizophrenia.
According to the FDA review, led by psychiatrist Phillip Kronstein, M.D., sertindole is effective in treating schizophrenia, but concerns remain about the drug's potential to prolong the heart's QT interval, which can lead to sudden cardiac death. That same cardiac risk has been seen in other antipsychotic drugs similar to sertindole.
Sertindole is a so-called atypical antipsychotic drug, Its specific mechanism appears to be to inhibit spontaneously active dopamine neurons in the mesolimbic ventral tegmental area without affecting dopamine neurons in the substantial nigra compacta.
READ MORE @ MADPAGE TODAY
Tuesday, April 7, 2009
Several Factors Predict Response to Treatment in Depressed Teens
Research findings answer many clinical questions on how to tailor interventions to varying adolescent patient characteristics based on individual and family factors.
Teenagers who suffer from antidepressant-resistant depression and have a concurrent history of family conflict, nonsuicidal self injury, or more severe symptoms of depression will likely have a poorer response to a new course of treatment, according to a study published in the March Journal of the American Academy of Child and Adolescent Psychiatry.
The study also found that adding cognitive-behavioral therapy (CBT) to antidepressant medications produces the most benefit for patients who have comorbidities such as anxiety disorders.
The study's findings can help clinicians individualize treatment plans for adolescents with more chronic and complicated forms of depression.
Analyzing the data from the Treatment-Resistant Depression in Adolescents (TORDIA) study, Joan Asarnow, Ph.D., a professor of psychiatry and behavioral sciences at the University of California at Los Angeles (UCLA) and the principal investigator of TORDIA at UCLA, and coauthors identified a number of patient characteristics that are associated with the likelihood of response to treatment and the benefit of medication—CBT combination therapy versus medication alone in this hard-to-treat population.
READ MORE @ PSYCHIATRIC NEWS
Teenagers who suffer from antidepressant-resistant depression and have a concurrent history of family conflict, nonsuicidal self injury, or more severe symptoms of depression will likely have a poorer response to a new course of treatment, according to a study published in the March Journal of the American Academy of Child and Adolescent Psychiatry.
The study also found that adding cognitive-behavioral therapy (CBT) to antidepressant medications produces the most benefit for patients who have comorbidities such as anxiety disorders.
The study's findings can help clinicians individualize treatment plans for adolescents with more chronic and complicated forms of depression.
Analyzing the data from the Treatment-Resistant Depression in Adolescents (TORDIA) study, Joan Asarnow, Ph.D., a professor of psychiatry and behavioral sciences at the University of California at Los Angeles (UCLA) and the principal investigator of TORDIA at UCLA, and coauthors identified a number of patient characteristics that are associated with the likelihood of response to treatment and the benefit of medication—CBT combination therapy versus medication alone in this hard-to-treat population.
READ MORE @ PSYCHIATRIC NEWS
Monday, April 6, 2009
Does Antipsychotic Treatment Impact Pediatric Health Care Costs?
Declining health care costs in pediatric patients treated with antipsychotic agents are being offset by the health care costs associated with the development of adverse events related to these medications.
Using retrospective data from South Carolina's Medicaid medical and pharmacy claims between January, 1996 and December, 2005, researchers Jeanette Jerrell, Ph.D., and Roger McIntyre, M.D., identified 4140 children and adolescents prescribed antipsychotic medications, and a random sample of 4500 children not treated with psychotropic medications. Their main outcome measures were total health care costs and emergency, inpatient, and outpatient services use over time, but they included pre-existing medical conditions, receipt of multiple psychotropic medications, and individual risk factor differences for gender, age group, and ethnicity in the analyses.
READ MORE @ MEDICAL NEWS TODAY
Using retrospective data from South Carolina's Medicaid medical and pharmacy claims between January, 1996 and December, 2005, researchers Jeanette Jerrell, Ph.D., and Roger McIntyre, M.D., identified 4140 children and adolescents prescribed antipsychotic medications, and a random sample of 4500 children not treated with psychotropic medications. Their main outcome measures were total health care costs and emergency, inpatient, and outpatient services use over time, but they included pre-existing medical conditions, receipt of multiple psychotropic medications, and individual risk factor differences for gender, age group, and ethnicity in the analyses.
READ MORE @ MEDICAL NEWS TODAY
Saturday, April 4, 2009
Cognitive Impairments Found With Attention-Deficit/Hyperactivity Disorder
Over the past century, the syndrome currently referred to as attention-deficit/hyperactivity disorder (ADHD) has been conceptualized in relation to varying cognitive problems including attention, reward response, executive functioning, and other cognitive processes.1 More recently, it has become clear that whereas ADHD is associated at the group level with a range of cognitive impairments, no single cognitive dysfunction characterizes all children with ADHD.2,3 In other words, ADHD is not a one-size-fits-all phenomenon. Patients with this syndrome do not fit into any one category and present with widely differing co-occurring disorders—including varying cognitive profiles.
Thus, ADHD represents not a single disease entity but a heterogeneous group of patients who require differentiated analysis, assessment, and treatment. This article focuses on the cognitive presentation of children (and, to a lesser extent, adults) with ADHD.
READ MORE @ PSYCHIATRIC TIMES
Thus, ADHD represents not a single disease entity but a heterogeneous group of patients who require differentiated analysis, assessment, and treatment. This article focuses on the cognitive presentation of children (and, to a lesser extent, adults) with ADHD.
READ MORE @ PSYCHIATRIC TIMES
Thursday, April 2, 2009
Schizophrenia - Novel Treatment May Provide Relief
A compound that naturally occurs in the brain and other areas of the body may be a promising new treatment for the most severe and disruptive symptoms of schizophrenia, according to researchers from Durham Veterans Affairs Medical Center and Duke University Medical Center.
Researchers conducted a pilot study that suggests the neurosteroid pregnenolone targets symptoms of schizophrenia for which no treatment options are available. The findings are published online in journal Neuropsychopharmacology.
While antipsychotic medications can help reduce hallucinations and delusions associated with schizophrenia for some patients, the other two categories of symptoms often continue to significantly disable patients -- negative symptoms, such as apathy, lack of emotion and poor social functioning, and cognitive symptoms, which include memory impairment and difficulty concentrating and completing tasks.
READ MORE @ HEALTH NEWS DIGEST
Researchers conducted a pilot study that suggests the neurosteroid pregnenolone targets symptoms of schizophrenia for which no treatment options are available. The findings are published online in journal Neuropsychopharmacology.
While antipsychotic medications can help reduce hallucinations and delusions associated with schizophrenia for some patients, the other two categories of symptoms often continue to significantly disable patients -- negative symptoms, such as apathy, lack of emotion and poor social functioning, and cognitive symptoms, which include memory impairment and difficulty concentrating and completing tasks.
READ MORE @ HEALTH NEWS DIGEST
Wednesday, April 1, 2009
Comorbidity in Bipolar Disorder The Complexity of Diagnosis and Treatment
The central tenet of clinical comorbidity, the occurrence of 2 syndromes in the same patient, presupposes that they are distinct categorical entities. By this definition, 2 or more coexisting syndromes do not negate one another, nor paradoxically does this coexistence negate the potential for one to influence the course, outcome, and treatment response of the other. Isolating a syndrome by characterizing it through a unique pathogenic process allows for diagnostic fidelity even while acknowledging overlapping phenotypes.
Bipolar disorder (BPD) is highly prevalent and heterogeneous. Its increasing complexity is often caused by the presence of comorbid conditions, which have become the rule rather than the exception. Lifetime prevalence of psychiatric comorbidity has been reported in community and clinical studies. Most (95%) of the respondents with BPD in the National Comorbidity Survey met criteria for 3 or more lifetime psychiatric disorders.1 In a Stanley Foundation Bipolar Treatment Outcome Network study of almost 300 patients, 65% met DSM-IV criteria for at least 1 comorbid Axis I disorder.2
Analogous to models in medicine (eg, cardiovascular disease), BPD incorporates psychiatric and medical comorbidities (Table) whose simultaneous treatment is equally pressing to the core mood disturbance.3 Checks and balances must be used to address the distressing comorbid condition (eg, anxiety) whose treatment with an SSRI or serotonin norepinephrine reuptake inhibitor (SNRI) may catalyze a round of mood cycling in an otherwise stable patient; a greater degree of protection via mood stabilizers may be warranted in such an individual to reduce this possibility.
Overall, the presence of comorbidities in BPD has negative prognostic implications for psychological health and for medical well-being and longevity.4-6 The most common comorbid conditions are reviewed below to help guide the clinician through this diagnostic maze and associated treatment considerations.
READ MORE @ PSYCHIATRIC TIMES
Bipolar disorder (BPD) is highly prevalent and heterogeneous. Its increasing complexity is often caused by the presence of comorbid conditions, which have become the rule rather than the exception. Lifetime prevalence of psychiatric comorbidity has been reported in community and clinical studies. Most (95%) of the respondents with BPD in the National Comorbidity Survey met criteria for 3 or more lifetime psychiatric disorders.1 In a Stanley Foundation Bipolar Treatment Outcome Network study of almost 300 patients, 65% met DSM-IV criteria for at least 1 comorbid Axis I disorder.2
Analogous to models in medicine (eg, cardiovascular disease), BPD incorporates psychiatric and medical comorbidities (Table) whose simultaneous treatment is equally pressing to the core mood disturbance.3 Checks and balances must be used to address the distressing comorbid condition (eg, anxiety) whose treatment with an SSRI or serotonin norepinephrine reuptake inhibitor (SNRI) may catalyze a round of mood cycling in an otherwise stable patient; a greater degree of protection via mood stabilizers may be warranted in such an individual to reduce this possibility.
Overall, the presence of comorbidities in BPD has negative prognostic implications for psychological health and for medical well-being and longevity.4-6 The most common comorbid conditions are reviewed below to help guide the clinician through this diagnostic maze and associated treatment considerations.
READ MORE @ PSYCHIATRIC TIMES
Monday, March 30, 2009
Depression Tests Urged for Teenagers
An influential government-appointed medical panel is urging doctors to perform routine screening on all American teenagers for depression, a step that acknowledges that nearly two million teenagers are affected by this debilitating condition.
Most are undiagnosed and untreated, said the panel, the United States Preventive Services Task Force, which sets guidelines for doctors on a host of health issues.
The task force recommendations appear in the April issue of the journal Pediatrics. And they go further than the American Academy of Pediatrics’ own guidance for screening of teenage depression.
An estimated 6 percent of American teenagers are clinically depressed. Evidence shows that detailed but simple questionnaires can accurately diagnose depression in primary-care settings like a pediatrician’s office.
The task force said that when followed by treatment, including psychotherapy, screening can help improve symptoms and help children cope. Because depression can lead to persistent sadness, social isolation, school problems and even suicide, screening to treat it early is crucial, the panel said.
READ MORE @ NY TIMES
Most are undiagnosed and untreated, said the panel, the United States Preventive Services Task Force, which sets guidelines for doctors on a host of health issues.
The task force recommendations appear in the April issue of the journal Pediatrics. And they go further than the American Academy of Pediatrics’ own guidance for screening of teenage depression.
An estimated 6 percent of American teenagers are clinically depressed. Evidence shows that detailed but simple questionnaires can accurately diagnose depression in primary-care settings like a pediatrician’s office.
The task force said that when followed by treatment, including psychotherapy, screening can help improve symptoms and help children cope. Because depression can lead to persistent sadness, social isolation, school problems and even suicide, screening to treat it early is crucial, the panel said.
READ MORE @ NY TIMES
Sunday, March 29, 2009
Psychiatric Disorders Are Common In Adults Who Have Had Anorexia
The study was initiated in 1985. A total of 51 teenagers with anorexia nervosa were studied, together with an equally large control group of healthy persons. The groups have been investigated and compared several times as the years have passed.
"This study is unique in an international perspective. It is the only study in the world that reflects the natural course of anorexia nervosa in the population", says Elisabet Wentz, Associate Professor in Child and Adolescent Psychiatry at the Sahlgrenska Academy.
The research group has published new results from the study in two scientific journals: the British Journal of Psychiatry and the International Journal of Eating Disorders.
Three women have still not recovered from anorexia, 18 years after the start of the study. Thirteen people, or around 25%, are on disability benefit or have been signed off sick for more than six months due to an eating disorder or other psychiatric disorder.. Thirty-nine percent have at least one other psychiatric disorder, in addition to the eating disorder. The most common of these is obsessive compulsive disorder.
READ MORE @ SCIENCE DAILY
"This study is unique in an international perspective. It is the only study in the world that reflects the natural course of anorexia nervosa in the population", says Elisabet Wentz, Associate Professor in Child and Adolescent Psychiatry at the Sahlgrenska Academy.
The research group has published new results from the study in two scientific journals: the British Journal of Psychiatry and the International Journal of Eating Disorders.
Three women have still not recovered from anorexia, 18 years after the start of the study. Thirteen people, or around 25%, are on disability benefit or have been signed off sick for more than six months due to an eating disorder or other psychiatric disorder.. Thirty-nine percent have at least one other psychiatric disorder, in addition to the eating disorder. The most common of these is obsessive compulsive disorder.
READ MORE @ SCIENCE DAILY
Friday, March 27, 2009
3 Researchers at Harvard Are Named in Subpoena
Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine.
The researchers — Drs. Joseph Biederman, Thomas Spencer and Timothy E. Wilens — are named in the subpoena, which was sent on Wednesday to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines.
READ MORE @ NY TIMES
The researchers — Drs. Joseph Biederman, Thomas Spencer and Timothy E. Wilens — are named in the subpoena, which was sent on Wednesday to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines.
READ MORE @ NY TIMES
Thursday, March 26, 2009
FDA Approves Olanzapine, Fluoxetine HCl for Treatment-Resistant Depression
The US Food and Drug Administration (FDA) has approved olanzapine and fluoxetine HCl (Symbyax) capsules for the indication of acute treatment of treatment-resistant depression (TRD) in adult patients who have not responded to 2 separate trials of different antidepressants of adequate dose and duration in their current episode.
An 8-week randomised, double-blind, controlled study evaluated the efficacy of olanzapine and fluoxetine HCl in patients (n=300) who met the fourth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD) and did not respond to 2 antidepressants of adequate dose and duration in their current episode.
READ MORE @ DOCTOR'S GUIDE
An 8-week randomised, double-blind, controlled study evaluated the efficacy of olanzapine and fluoxetine HCl in patients (n=300) who met the fourth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD) and did not respond to 2 antidepressants of adequate dose and duration in their current episode.
READ MORE @ DOCTOR'S GUIDE
Wednesday, March 25, 2009
Inherited Depression Risk Linked to Brain Structure Abnormalities
Depression risk passed down through families may be due, in part, to structural thinning in a region of the brain that processes social and emotional stimuli, researchers said.
People with a family history of major depression had a 28% reduction in the thickness of gray matter in the right cerebral hemisphere compared to people with no known risk, Bradley Peterson, M.D., of the Columbia University Medical Center and New York State Psychiatric Institute, and colleagues found.
The effect was "remarkable for its magnitude and spatial extent," rivaling morphological abnormalities of the most severe neuropsychiatric disorders, including schizophrenia and Alzheimer's diseases, they reported online in the Proceedings of the National Academy of Sciences.
READ MORE @ MEDPAGE TODAY
People with a family history of major depression had a 28% reduction in the thickness of gray matter in the right cerebral hemisphere compared to people with no known risk, Bradley Peterson, M.D., of the Columbia University Medical Center and New York State Psychiatric Institute, and colleagues found.
The effect was "remarkable for its magnitude and spatial extent," rivaling morphological abnormalities of the most severe neuropsychiatric disorders, including schizophrenia and Alzheimer's diseases, they reported online in the Proceedings of the National Academy of Sciences.
READ MORE @ MEDPAGE TODAY
Tuesday, March 24, 2009
Biomarkers of Illness and Treatment
Research on biological markers of disease process and treatment response were highlighted at the 48th annual New Clinical Drug Evaluation Unit meeting, “New Research Approaches for Mental Health Interventions,” convened by the NIMH, May 27-30 in Phoenix.
In a workshop on biomarkers, pharmacogenetics, and pharmacogenomics, Michael Henry, MD, of Caritas St Elizabeth’s Medical Center in Boston, indicated that technological improvements in scanner design, along with increasing understanding of neuropathophysiology, “offer an unprecedented opportunity for utilizing brain imaging techniques to improve the precision of clinical trials.”
Henry foresees the application of technologies such as MRI, PET, and single photon emission CT to reduce diagnostic variability in study populations, measure drug penetration of target sites, and establish biomarkers of therapeutic efficacy. Although imaging in clinical trials is most common in cardiology and oncology, Henry noted its recent use in trials of agents for dementia, depression, and psychosis.
Andrew Leon, PhD, of Weill Medical College of Cornell University, New York, agreed with the described potential of biomarkers to serve as primary end points in clinical trials but reminded conferees that the current status is either as secondary end points or “hypothesized moderators of outcome.” To go forward, he asserted, clinical trials will need to include validity testing of putative biomarkers.
READ MORE @ PSYCHIATRIC TIMES
In a workshop on biomarkers, pharmacogenetics, and pharmacogenomics, Michael Henry, MD, of Caritas St Elizabeth’s Medical Center in Boston, indicated that technological improvements in scanner design, along with increasing understanding of neuropathophysiology, “offer an unprecedented opportunity for utilizing brain imaging techniques to improve the precision of clinical trials.”
Henry foresees the application of technologies such as MRI, PET, and single photon emission CT to reduce diagnostic variability in study populations, measure drug penetration of target sites, and establish biomarkers of therapeutic efficacy. Although imaging in clinical trials is most common in cardiology and oncology, Henry noted its recent use in trials of agents for dementia, depression, and psychosis.
Andrew Leon, PhD, of Weill Medical College of Cornell University, New York, agreed with the described potential of biomarkers to serve as primary end points in clinical trials but reminded conferees that the current status is either as secondary end points or “hypothesized moderators of outcome.” To go forward, he asserted, clinical trials will need to include validity testing of putative biomarkers.
READ MORE @ PSYCHIATRIC TIMES
Monday, March 23, 2009
FDA approves antidepressant Lexapro for adolescents
The decision comes after Justice Department allegations that the drug's maker, Forest Laboratories, had improperly induced pediatricians to prescribe it and a similar pill, Celexa.
Just weeks after prosecutors accused Forest Laboratories Inc. of illegally marketing its antidepressants Celexa and Lexapro to children and paying pediatricians kickbacks, U.S. health regulators Friday approved Lexapro for depression in kids.
Forest said Lexapro was approved by the U.S. Food and Drug Administration to treat major depressive disorder in adolescents aged 12 to 17 and as a maintenance therapy to control symptoms. It is already approved for adults, and registers annual sales of more than $2 billion.
The FDA on Friday approved Lexapro's use for adolescents based on favorable results in two clinical trials -- one involving adolescents taking Lexapro and another involving children and adolescents taking the chemically similar Celexa, Forest said.
READ MORE @ LOS ANGELES TIMES
Just weeks after prosecutors accused Forest Laboratories Inc. of illegally marketing its antidepressants Celexa and Lexapro to children and paying pediatricians kickbacks, U.S. health regulators Friday approved Lexapro for depression in kids.
Forest said Lexapro was approved by the U.S. Food and Drug Administration to treat major depressive disorder in adolescents aged 12 to 17 and as a maintenance therapy to control symptoms. It is already approved for adults, and registers annual sales of more than $2 billion.
The FDA on Friday approved Lexapro's use for adolescents based on favorable results in two clinical trials -- one involving adolescents taking Lexapro and another involving children and adolescents taking the chemically similar Celexa, Forest said.
READ MORE @ LOS ANGELES TIMES
Saturday, March 21, 2009
Older drug seen better for Parkinson's depression
People with Parkinson's disease who need treatment for depression seem to do better with an older antidepressant than a newer agent, according to a small clinical trial.
"Individuals with depression and Parkinson's disease do respond to antidepressants," Dr. Matthew Menza told Reuters Health. "This is important because depression in Parkinson's disease is often under-recognized, under-appreciated and under-treated. Commonly, the attitude is, 'of course you're depressed, you have a serious illness.' We have now demonstrated that one should be hopeful that treatment will help."
There have been few head-to-head trials of different antidepressants for Parkinson's patients with depression, Menza, of the Robert Wood Johnson Medical School in Piscataway, New Jersey, and his group note in the medical journal Neurology.
To investigate, they compared the older "tricyclic" antidepressant nortriptyline with the newer "SSRI" agent paroxetine in 52 people with Parkinson's disease diagnosed with major depression. Nortriptyline is available in generic form and under the brand name Pamelor, and paroxetine CR is known by the brand names Paxil and Seroxat.
READ MORE @ REUTERS
"Individuals with depression and Parkinson's disease do respond to antidepressants," Dr. Matthew Menza told Reuters Health. "This is important because depression in Parkinson's disease is often under-recognized, under-appreciated and under-treated. Commonly, the attitude is, 'of course you're depressed, you have a serious illness.' We have now demonstrated that one should be hopeful that treatment will help."
There have been few head-to-head trials of different antidepressants for Parkinson's patients with depression, Menza, of the Robert Wood Johnson Medical School in Piscataway, New Jersey, and his group note in the medical journal Neurology.
To investigate, they compared the older "tricyclic" antidepressant nortriptyline with the newer "SSRI" agent paroxetine in 52 people with Parkinson's disease diagnosed with major depression. Nortriptyline is available in generic form and under the brand name Pamelor, and paroxetine CR is known by the brand names Paxil and Seroxat.
READ MORE @ REUTERS
Friday, March 20, 2009
Risperdal Researcher Promised Drug Maker Positive Results from Clinical Trials
A prominent Harvard psychiatrist promised positive results to Johnson & Johnson before the start of some clinical trials for Risperdal. According to The Wall Street Journal, the revelations regarding Dr. Joseph Biederman came to light in court documents that are part of a lawsuit involving Risperdal and other atypical antipsychotic drugs. While he is not a defendant in the case, Biederman was called as a witness to illustrate the questionable financial ties between drug makers and the research community.
Some of the 2,000 plaintiffs involved in the multi-state lawsuit are children. Risperdal wasn’t approved for use in children until 2007. However, it is known that doctors prescribed the drug off-label for thousands of children years before that. While off-label prescribing is legal, drug companies are legally barred from marketing off-label uses. But according to The Boston Globe, the companies often skirt that prohibition by paying respected “opinion leaders” - usually top experts in their field - to discuss their off-label prescribing experiences at “educational” talks or meetings.
As we reported last November, Biederman was one of those opinion leaders. Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder. The lawsuit has raised questions about Biederman’s role in convincing Johnson & Johnson’s to fund a center on pediatric bipolar disorder at Harvard’s Massachusetts General Hospital.
READ MORE @ NEWS INFERNO
Some of the 2,000 plaintiffs involved in the multi-state lawsuit are children. Risperdal wasn’t approved for use in children until 2007. However, it is known that doctors prescribed the drug off-label for thousands of children years before that. While off-label prescribing is legal, drug companies are legally barred from marketing off-label uses. But according to The Boston Globe, the companies often skirt that prohibition by paying respected “opinion leaders” - usually top experts in their field - to discuss their off-label prescribing experiences at “educational” talks or meetings.
As we reported last November, Biederman was one of those opinion leaders. Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder. The lawsuit has raised questions about Biederman’s role in convincing Johnson & Johnson’s to fund a center on pediatric bipolar disorder at Harvard’s Massachusetts General Hospital.
READ MORE @ NEWS INFERNO
Thursday, March 19, 2009
Common Anticonvulsants May Raise Epileptics' Cardio Risk
Two widely prescribed anticonvulsants appear to increase cardiovascular risk in epileptics, researchers here found.
Patients who were switched from phenytoin or carbamazepine to newer medications had significant drops in cholesterol, C-reactive protein, and other markers of cardiovascular disease risk, Scott Mintzer, M.D., of Thomas Jefferson University here, and colleagues reported online in Annals of Neurology.
The researchers said it was unlikely the improvements resulted from treatment with the newer drugs.
"It's a consequence of being taken off the older ones, which were causing the cholesterol and other markers to be elevated in the first place," Dr. Mintzer said.
READ MORE @ MEDPAGE TODAY
Patients who were switched from phenytoin or carbamazepine to newer medications had significant drops in cholesterol, C-reactive protein, and other markers of cardiovascular disease risk, Scott Mintzer, M.D., of Thomas Jefferson University here, and colleagues reported online in Annals of Neurology.
The researchers said it was unlikely the improvements resulted from treatment with the newer drugs.
"It's a consequence of being taken off the older ones, which were causing the cholesterol and other markers to be elevated in the first place," Dr. Mintzer said.
READ MORE @ MEDPAGE TODAY
Wednesday, March 18, 2009
Changing Rx Practices in the Treatment of Mental Illness: Impact on Forensic Evidence
"Off-label" prescription practices are increasingly used in the treatment of symptoms related to mental illness. In support of this conclusion, evidence is reviewed on the antidepressant treatment of numerous non-depressive disorders and on the antipsychotic drug treatment of non-psychotic disorders. The impact of this evidence is discussed in light of the Daubert decision rendered by the U.S. Supreme Court. It is concluded that such practices challenge the application of the decision and increase the potential for testimonial error. Finally, a promising trend of identifying drugs by their neurochemical action is briefly discussed.
One trend that has revolutionized the face of Clinical Psychopharmacology is a breakdown in the disorder-specific nature of drug treatment (i.e., the use of antidepressant drugs to treat depression, antipsychotic drugs to treat psychosis, etc.). This "off-label" prescription practice has resulted in a clear broadening of the range of possible psychological symptoms that can be positively influenced by a specific class of drugs. The purpose of this article is to present examples of this practice in the published literature and suggest how this trend has impacted forensic considerations in the area of Clinical Psychopharmacology. Although no attempt has been made to exhaust coverage of this trend, an attempt has been made to present examples representative of different classes of drugs.
READ MORE @ THE FORENSIC EXAMINER
One trend that has revolutionized the face of Clinical Psychopharmacology is a breakdown in the disorder-specific nature of drug treatment (i.e., the use of antidepressant drugs to treat depression, antipsychotic drugs to treat psychosis, etc.). This "off-label" prescription practice has resulted in a clear broadening of the range of possible psychological symptoms that can be positively influenced by a specific class of drugs. The purpose of this article is to present examples of this practice in the published literature and suggest how this trend has impacted forensic considerations in the area of Clinical Psychopharmacology. Although no attempt has been made to exhaust coverage of this trend, an attempt has been made to present examples representative of different classes of drugs.
READ MORE @ THE FORENSIC EXAMINER
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