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.