Psychotropic profiles of ipsapirone and diazepam alone and in combination with alcohol in normal volunteers : a placebo-controlled double-blind study.

This paper presents a German study that investigated cognitive, psychomotor and subjective efforts of ipsapirone, diazepam, and a placebo, after multiple administration and together with alcohol. Some of these data have already been presented elsewhere. 36 healthy volunteers of both sexes, aged 22 to 50, participated in this study. Under double blind conditions, they were assigned at random to three treatments: (1) ipsapirone; (2) an ipsapirone-like diazepam preparation; (3) an identical-appearing placebo. In the first week, they were tested under drug-free conditions. In the second week, the treatments started. In the third week, alcohol was also administered. Each test session lasted about 1.75 hours, and subjects were given various psychological, performance and reaction time tests. Various statistical analyses were applied to the data, including t-tests and an analysis of covariance. There were no clear overall differences between the three treatments for the psychotropic effects and performance tests, but diazepam showed the worst reaction time and the placebo the best, with ipsapirone giving intermediate results. The main adverse reactions reported were symptoms of muscle relaxation under diazepam and more frequent dizziness under ipsapirone.