ELTOPRAZINE IN AGGRESSIVE MENTALLY-HANDICAPPED PATIENTS - A DOUBLE-BLIND, PLACEBO-CONTROLLED AND BASE-LINE-CONTROLLED MULTICENTER STUDY

The efficacy of eltoprazine, a mixed 5-HT1 agonist, in treating aggres sive behaviour in mentally handicapped patients was evaluated in a dou ble-blind, placebo- and baseline-controlled study. In the total sample of 160 patients who entered the 8 week double-blind treatment phase, efficacy was not demonstrated. Also in a 28 week double-blind follow-u p study, efficacy could not be demonstrated. Post-hoc exploratory anal yses suggested eltoprazine was significantly better than placebo in re ducing aggression scores of a subgroup of severely aggressive patients . There was no evident relationship between the plasma level of eltopr azine and therapeutic effect or safety and tolerance. The overall safe ty and tolerance of chronic eltoprazine treatment was goad. In the dis cussion, several issues and pitfalls of aggression research are dealt with.