[The AMDP scales in a phase II evaluation of psychotropic drugs]

Four multicentre double blind trials (two studies comparing placebo to a marketed activating drug and two comparing placebo to a new drug with central adrenergic modulating properties) were pooled, totalling 77 placebo Ss, 30 reference drug Ss and 73 study drug Ss. The AMDP-4 and -5 scales were filled out at day 0 and 7 by trained raters. Four statistical analyses were performed on the pre- vs. postdrug differences: an analysis of variance, a principal components factor analysis, a discriminant analysis and a cluster analysis. The results indicate that 9 out of the 14 AMDP factor scores significantly decrease within 1 week while the factor Mania-Agitation increases, without differences between both active compounds; on the item level, the "inhibition of drive" is specifically improved by the study drug; the discriminant analysis confirms that the two most improved items are "Inhibition of drive" and "Hopelessness". Three factor scores significantly improve on placebo (Depression, Retardation, Psycho-organic Symptoms), which points to the necessity of placebo-controlled studies in clinical trials of new drugs.