Antipsychotics in Children: Experts Report Mixed Results
December 1st 2008Studies of antipsychotics in child prenpresented at the 48th Annual New Clinical Drugs Evaluation Unit (NCDEU) Meeting, conducted by the NIMH in Phoenix, May 27-30, provide some data where there have been relatively little on the increasing use of these agents.
NIMH Plans Accelerating Research to Remedies
October 1st 2008A strategic plan to guide research priorities and resource allocations of the NIMH was released recently by NIMH Director, Thomas R. Insel, MD. The plan is intended to provide direction over the next 5 years toward the institute’s stated vision of “a world in which mental illnesses are prevented and cured.”
Last Minute Drug Approvals Linked to Postmarket Safety Issues
August 1st 2008Drugs approved by the FDA just before mandated deadlines are more likely to have safety issues after entering the market than those approved at other times, according to a study in the March 27 New England Journal of Medicine.1 Coincidentally, on that date, the FDA announced the first group of marketed medications, including the atypical antipsychotic clozapine (Clozaril), for which it is requiring additional safety plans under the FDA Amendments Act of 2007.
Antipsychotic Use Questioned for Developmentally Disabled
June 2nd 2008Two new studies of antipsychotic efficacy for nonpsychotic behaviors in persons with developmental disability provide data where there has been relatively little, but their contrary findings leave this a controversial use of medication.
Dual-Diagnosis Patients: Slow Progress in Improving Care
March 1st 2008The therapeutic challenges presented by comorbid psychiatric and substance abuse disorders, along with strategies and initiatives to improve treatment, were the focus of a recent collection of studies and reviews in the Journal of Substance Abuse Treatment.
Evidence Grows for Value of Antipsychotics as Antidepressant Adjuncts
February 1st 2008The FDA recently approved the use of aripiprazole (Abilify) in combination with antidepressant medication for the treatment of major depression in adults. Although a variety of agents have been used in efforts to augment the effect of antidepressants, this first approved adjunct is likely to increase this use of atypical antipsychotics.
Medications for Agitation in Dementia: Seeking Efficacy With Safety References
January 1st 2008Almost 3 years after the FDA warned of increased mortality in elderly patients who received atypical antipsychotics off-label for neuropsychiatric syndromes of dementia, no medication has been approved as safe and effective for this increasingly challenging problem. Recent publications, however, including a white paper from the American College of Neuropsychopharmacology (ACNP), indicate that clinical investigators are wrestling with the dilemma and considering potential alternatives to antipsychotics.
New Compounds, Novel Applications Described
January 1st 2008Several new substances and new uses for available products were evaluated in research projects reported at the 47th annual NIMH-sponsored New Clinical Drug Evaluation Unit, held this past June in Boca Raton, Fla. The agonists included a melatonergic compound for depression, 2 new agents for schizophrenia, some g-aminobutyric acid (GABA)-ergic antipsychotics, and several drugs being evaluated for non-approved indications.
New Drug Evaluation Workshops Focus on Improving Psychiatric Research
December 1st 2007Precision of psychiatric drug safety assessments, availability of adequately trained psychiatric researchers, and participation of a diverse research population were prominent among the topics of several panels and workshops on research methodology at the NIMH-sponsored 47th annual New Clinical Drug Evaluation Unit (NCDEU) meeting that took place earlier this year in Boca Raton, Fla.
Strategies Against Methamphetamine and Cocaine Described at ASAM Meeting
November 1st 2007Widespread media reports and billboard campaigns decrying a methamphetamine epidemic are drawing attention away from the greater and more entrenched use of cocaine, according to a National Institute of Drug Abuse (NIDA) scientist speaking at the American Society of Addiction Medicine's (ASAM) 38th Annual Medical-Scientific Conference, held in Miami, April 26 to 29.
Bone Density Loss in Elderly Related to Depression, SSRI Therapy
October 1st 2007Bone mineral density (BMD) was reduced at a greater rate in older women when they had symptoms of depression, according to one recent report from the Study of Osteoporotic Fractures Research Group, while another report implicated treatment with SSRI antidepressants.
Abuse of Prescription Drugs Close Behind Alcohol, Marijuana
September 1st 2007About 60% of users of illegal prescription drugs receive them free from friends or relatives, H. Westley Clark, MD, JD, director, Center for Substance Abuse Treatment (CSAT), of the federal Substance Abuse and Mental Health Services Administration (SAMHSA), told attendees at the American Society of Addiction Medicine 38th Annual Medical-Scientific Conference
Suicide in Depression: Balancing Risk Factors, Identifying Vulnerable Patients
August 1st 2007This May, the FDA called for a black box warning on antidepressants to indicate that patients aged 18 to 24 years are at heightened risk for treatment-emergent suicidality. But a member of the FDA advisory committee that recommended that warning has issued his own warning, saying that the "real killer in this story is untreated depression and the possible risk from antidepressant treatment is dwarfed by that from the disease."
Antidepressants Evidence Salutary Effects for Stroke Patients
July 1st 2007The results of two recent studies suggest that antidepressant medication may have an expanded role in the management of stroke patients. Prophylactic use of antidepressants following stroke appeared in a meta-analysis to be effective in fending off depression, and a short course of antidepressants in a placebo-controlled study was associated with long-term restoration of executive function, independent of depressive symptoms.
Depression With Coronary Disease: Therapy Adds No Benefit to SSRI
June 1st 2007In what was billed as the first randomized controlled study to simultaneously evaluate antidepressant therapy and short-term psychotherapy for depressed patients with coronary artery disease (CAD), treatment with an SSRI led to significant improvement, while addition of interpersonal psychotherapy provided no added benefit.
Bipolar Disorder: No Improvement With Addition of an Antidepressant
June 1st 2007The addition of an antidepressant to a mood stabilizer did not add any benefit for patients with bipolar depression, according to an NIMH-sponsored research project reported in April in the New England Journal of Medicine. In the multicenter study, adding an antidepressant to the regimen also did not increase affective switching to mania.
Drug Effects: Do Test Results Correlate With Clinical Gains?
March 3rd 2007There are any number of ways to measure the effects of psychoactive medications, ranging from objective assessments of behavioral change to neuropsychological testing to subjective global ratings by physicians or patients. Several recent studies have examined the question of whether medication-induced improvements in neuropsychological test performance correlated with gains in healthful functioning.
STAR*D Starts to Resemble Practice
March 1st 2007When clinical practice appears to diverge from evidence-based medicine, is the clinician departing from science, or are the data not applying to practice? The challenge of developing clinical research data to inform treatment strategies for the inconstant course of psychiatric illness was recently considered by Susan Murphy, PhD, of the University of Michigan's Institute for Social Research, with colleagues from the MCATS (Methodology for Constructing Adaptive Treatment Strategies) network, and John Rush, MD, of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) investigators group.
FDA, NIMH Scrutinize Antidepressant-Linked Suicidality
March 1st 2007In a meeting this past December, an FDA advisory committee recommended that the black-box warning of antidepressant-linked suicidality in children and adolescents should also warn of the risk in young adults. Meanwhile, the NIMH had announced in November its sponsorship of 5 new studies to elucidate this adverse drug effect, particularly focusing on the SSRI antidepressants.
Assessing Statins for Alzheimer Disease: Conflicting Evidence
February 1st 2007The second report from the Alzheimer's Disease Cholesterol-Lowering Treatment (ADCLT) trial was recently published, along with several reviews of clinical and laboratory investigations of the statins, in a theme issue of Acta Neurologica Scandinavica. The accumulated data reflect the potential of the agents to affect the onset or course of Alzheimer disease (AD), with contradictory or insufficient evidence of treatment effect.
New Compounds, Novel Strategies Reported at NCDEU
November 1st 2006Investigational drugs and novel applications of established agents for psychiatric illness were described in a number of reports at the 46th annual NIMH-sponsored New Clinical Drug Evaluation Unit (NCDEU) meeting in Boca Raton, Fla, June 12-15, 2006.
Better Tools Needed to Measure Treatment Outcome
October 1st 2006The need for better tools, as well as better use of existing tools, to measure treatment response in clinical trials was a principle focus of the 46th annual NIMH-sponsored NCDEU (New Clinical Drug Evaluation Unit) meeting, held June 12-15 in Boca Raton, Fla. Improved clinical research techniques are needed to better separate treatment effect from placebo response, to distinguish between active comparators, and to facilitate development of novel treatments, according to several presenters at the conference.