Eltoprazine in aggressive mentally handicapped patients: a double-blind, placebo- and baseline-controlled multi-centre study. The Eltoprazine Aggression Research Group.
The efficacy of eltoprazine, a mixed 5-HT1 agonist, in treating aggressive behaviour in mentally handicapped patients was evaluated in a double-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-up study, efficacy could not be demonstrated. Post-hoc exploratory analyses suggested eltoprazine was significantly better than placebo in reducing aggression scores of a subgroup of severely aggressive patients. There was no evident relationship between the plasma level of eltoprazine and therapeutic effect or safety and tolerance. The overall safety and tolerance of chronic eltoprazine treatment was good. In the discussion, several issues and pitfalls of aggression research are dealt with.
de Koning
P
P
Department of Clinical Pharmacology, Solvay Duphar BV, Weesp, The Netherlands.
Mak
M
M
de Vries
M H
MH
Allsopp
L F
LF
Stevens
R B
RB
Verbruggen
R
R
Van den Borre
R
R
van Peteghem
P
P
Kohen
D
D
Arumainayagam
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000374:Aggression / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008607:Intellectual Disability / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D010552:Personality Assessment; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D017366:Serotonin Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D012919:Social Behavior; D016896:Treatment Outcome
D010879:Piperazines; D017366:Serotonin Receptor Agonists; C063828:eltoprazine