Kenneth J. Bender, PharmD, MA

Articles by Kenneth J. Bender, PharmD, MA

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.

About 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

This 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."

The 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.

There 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.

When 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.

In 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.

The 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.

The 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.