A randomized, double-blind, placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder.

Full Abstract

OBJECTIVE:
To investigate the safety and efficacy of aripiprazole in preventing relapse of a mood episode in recently manic- or mixed-episode patients with bipolar I disorder stabilized on aripiprazole.

METHOD:
This randomized, double-blind, parallel-group, placebo-controlled, multicenter study enrolled patients from 76 centers in 3 countries (Argentina, Mexico, United States) from March 2000 to June 2003. Bipolar I disorder (DSM-IV) patients who had recently been hospitalized and treated for a manic or mixed episode entered an open-label stabilization phase (aripiprazole monotherapy:
15 or 30 mg/day, 6-18 weeks). After meeting stabilization criteria (Young Mania Rating Scale score of < or = 10 and Montgomery-Asberg Depression Rating Scale score of < or = 13 for 6 consecutive weeks), 161 patients were randomly assigned to aripiprazole or placebo for the 26-week, double-blind phase. The primary endpoint was time to relapse for a manic, mixed, or depressive episode (defined by discontinuation caused by lack of efficacy).

RESULTS:
Aripiprazole was superior to placebo in delaying the time to relapse (p = .020). Aripiprazole-treated patients had significantly fewer relapses (25%) than placebo patients (43%; p = .013). Aripiprazole was superior to placebo in delaying the time to manic relapse (p = .01); however, no significant differences were observed in time to depressive relapse (p = .68). Weight gain (> or = 7% increase) occurred in 7 (13%) aripiprazole-treated and 0 placebo-treated patients. Adverse events (> or = 5% incidence and twice that of placebo) reported by aripiprazole-treated patients were akathisia, pain in the extremities, tremor, and vaginitis.

CONCLUSIONS:
Aripiprazole, 15 or 30 mg/day, was superior to placebo in maintaining efficacy in patients with bipolar I disorder with a recent manic or mixed episode who were stabilized and maintained on aripiprazole treatment for 6 weeks, as shown by a longer time to relapse.

Learn Faster Today Improve your study skills

Author information

Author/s: Keck, Paul E (PE); Calabrese, Joseph R (JR); McQuade, Robert D (RD); Carson, William H (WH); Carlson, Berit X (BX); Rollin, Linda M (LM); Marcus, Ronald N (RN); Sanchez, Raymond (R); Aripiprazole Study Group;

Affiliation: Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267, USA. paul.keck(-atsign-)uc.edu

Journal and publication information

Publication Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: The Journal of clinical psychiatry (J Clin Psychiatry), published in United States. (Language: eng)

Reference: 2006-Apr; vol 67 (issue 4) : pp 626-37

Dates: Created 2006/05/03; Completed 2006/06/16; Revised 2007/02/12;

PMID: 16669728, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

Comments and Corrections

CommentIn: Evid Based Ment Health. 2007 Feb;10(1):13. (PMID: 17255382)

External Links for this article (including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.

MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adult
Akathisia, Drug-Induced - etiology
Antipsychotic Agents - adverse effects; therapeutic use
Bipolar Disorder - drug therapy; psychology
Cross-Cultural Comparison
Double-Blind Method
Female
Humans
International Cooperation

Male
Pain - chemically induced
Piperazines - adverse effects; therapeutic use
Placebos
Psychiatric Status Rating Scales
Quinolones - adverse effects; therapeutic use
Recurrence - prevention & control
Time Factors
Treatment Outcome

Associated Chemicals: Antipsychotic Agents (0) ; Piperazines (0) ; Placebos (0) ; Quinolones (0) ; aripiprazole (129722-12-9)

These are the highest related articles currently in the database:

See 100+ related articles.