The impact of favorable and unfavorable life events on psychotropic drug response.

A group of 410 primarily anxious psychiatric outpatients treated with chlordiazepoxide, 244 treated with diazepam, and 537 receiving placebo were asked to report any significant favorable or unfavorable life events which occurred during both the first and the second 2 weeks of a 4-week double-blind drug trial. The frequency with which favorable and unfavorable events were reported did not differ across medication groups. However, patients reporting unfavorable events showed significantly less improvement after 2 and 4 weeks of treatment than did patients reporting no events or patients reporting favorable events. The amount of improvement experienced by patients reporting positive events did not differ significantly from that of patients reporting no events. The size of the impact of reported events upon outcome did not vary with treatment agents. Essentially similar results were obtained when data based on 2- and 4-week patient improvement ratings were analyzed. It was concluded that the occurrence of significant life events during the course of drug trials of the type involved here did not affect the sensitivity with which drug-placebo differences could be detected.

RCT Entities:   Population Interventions Outcomes