Kenneth J. Bender, PharmD, MA

Articles by Kenneth J. Bender, PharmD, MA

The empirical basis for the effectiveness of 12-step recovery and the psychotherapeutic benefits of opioid agonist maintenance were among the topics of several symposia with introspective views of time-tested treatments at the 40th Annual Medical-Scientific Conference of the American Society of Addiction Medicine (ASAM) in New Orleans.

A study of the adverse effects of 4 second-generation antipsychotics in children and adolescents documented substantial weight gain during 11 weeks of treatment with each agent, with the increased abdominal fat that has been associated with development of metabolic syndrome in adults. Metabolic abnormalities emerged with 3 of the 4 agents, differing in type and severity with the agent and, in some cases, with the dose.

The NIMH-sponsored New Clinical Drugs Evaluation Unit (NCDEU) meeting is a favored venue for reports and reviews of NIH-funded psychopharmacological studies, and this was true of the recent annual meeting in Hollywood, Fla. The meeting included a workshop on new investigations of antidepressant use in Alzheimer disease and a panel session on the safety of pharmacotherapy in older adults.

The FDA recently approved iloperidone (Fanapt, Vanda Pharmaceuticals) for the treatment of schizophrenia, reversing a July 2008 determination that the New Drug Application (NDA) was “not approvable.” An FDA spokesperson explained in an interview in Forbes (May 8), “Vanda provided the FDA with additional data and arguments that led us to reinterpret results of several of their studies.”

Second-generation (atypical) antipsychotic drugs may not have an advantage for cardiovascular risk over typical antipsychotics, according to a recent, large retrospective cohort study. Researchers at the Vanderbilt University School of Medicine in Tennessee found that risk of sudden cardiac death is heightened with antipsychotics, whether typical or atypical, and the risk increases significantly with increasing doses.

Patients who have had a myo­cardial infarction (MI) should be screened and appropriately treated for depression, according to a guideline recently issued by the American Academy of Family Physicians (AAFP).1 The group recommends use of a standardized depression symptom checklist during hospitalization and “at regular intervals” thereafter.

A 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.”

Drugs 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.

Almost 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.

Several 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.

Precision 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.