P. Dekoning et al., ELTOPRAZINE IN AGGRESSIVE MENTALLY-HANDICAPPED PATIENTS - A DOUBLE-BLIND, PLACEBO-CONTROLLED AND BASE-LINE-CONTROLLED MULTICENTER STUDY, International clinical psychopharmacology, 9(3), 1994, pp. 187-194
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.