Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study.
BACKGROUND
Well-tolerated and effective therapies for bipolar mania are required.


OBJECTIVE
To evaluate the efficacy and tolerability of aripiprazole as acute and maintenance of effect therapy in patients with bipolar I disorder experiencing manic or mixed episodes.


METHODS
Patients were randomised to double-blind aripiprazole (15 or 30 mg/day; n=167), placebo (n=153) or haloperidol (5-15 mg/day, n=165) for 3 weeks (trial registration NCT00097266). Aripiprazole- and haloperidol-treated patients remained on masked treatment for 9 additional weeks.


RESULTS
Mean change in Young Mania Rating Scale Total score (primary end-point) at week 3 was significantly greater with aripiprazole (-12.0; P<0.05) and haloperidol (-12.8; P<0.01) than with placebo (-9.7). Improvements were maintained to week 12 for aripiprazole (-17.2) and haloperidol (-17.8). Aripiprazole was well tolerated. Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole (53.3% v. 23.5%).


CONCLUSIONS
Clinical improvements with aripiprazole were sustained to week 12. Aripiprazole was generally well tolerated.
Young
Allan H
AH
Institute of Mental Health, Department of Psychiatry, University of British Columbia, Vancouver, Canada. allanyoun@gmail.com
Oren
Dan A
DA
Lowy
Adam
A
McQuade
Robert D
RD
Marcus
Ronald N
RN
Carson
William H
WH
Spiller
Nina H
NH
Torbeyns
Anne F
AF
Sanchez
Raymond
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole; D006220:Haloperidol