Efficacy and safety of aripiprazole in subpopulations with acute manic or mixed episodes of bipolar I disorder.

Full Abstract

BACKGROUND:
This analysis was designed to assess the efficacy and safety of aripiprazole compared with placebo in subpopulations of patients with acute manic or mixed episodes of bipolar I disorder.

METHODS:
Acutely manic patients experiencing DSM-IV manic/mixed episodes of bipolar I disorder were pooled from two randomized, three-week, flexible-dose, double-blind, placebo-controlled trials (N=516) and stratified by disease severity (Young Mania Rating Scale, YMRS), episode type, presence or absence of psychotic features, episode frequency, age, gender, and baseline severity of depressive symptoms. Safety and treatment-emergent adverse-event analyses were also performed.

RESULTS:
Aripiprazole significantly reduced mean YMRS total scores at end point compared with placebo in patients with more severe or less severe illness, with mixed or manic episodes, with or without psychotic features, or with a history of rapid or non-rapid cycling (p<0.01 for each subpopulation); in men and women (p=0.001 for both); in patients in the 18-40 and 41-55 year age groups (p<or=0.001 for both); and in three subgroups stratified by baseline severity of depressive symptoms using the Montgomery-Asberg Depression Rating Scale (p<0.05). The treatment-emergent adverse events reported in >or=5% of patients aged 18-40 years receiving aripiprazole were similar to those reported for the overall population.

LIMITATIONS:
This post hoc analysis utilized pooled data from two short-term studies.

CONCLUSION:
Efficacy of the second-generation antipsychotic aripiprazole was noted across a broad range of subpopulations often associated with treatment resistance in patients experiencing manic or mixed episodes of bipolar I disorder.

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Author information

Author/s: Suppes, Trisha (T); Eudicone, James (J); McQuade, Robert (R); Pikalov, Andrei (A); Carlson, Berit (B);

Affiliation: Bipolar Disorder Research Program, UT Southwestern Medical Center, Dallas, Texas 75390-9121, USA. trisha.suppes(-atsign-)utsouthwestern.edu

Journal and publication information

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

Journal: Journal of affective disorders (J Affect Disord), published in Netherlands. (Language: eng)

Reference: 2008-Apr; vol 107 (issue 1-3) : pp 145-54

Dates: Created 2008/03/03; Completed 2008/05/27;

PMID: 17904226, status: MEDLINE (last retrieval date: 11/6/2008)

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

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Acute Disease
Adolescent
Adult
Age Distribution
Akathisia, Drug-Induced - etiology
Antipsychotic Agents - adverse effects; therapeutic use
Bipolar Disorder - drug therapy; psychology
Diagnostic and Statistical Manual of Mental Disorders
Double-Blind Method
Female

Female
Humans
Male
Middle Aged
Piperazines - adverse effects; therapeutic use
Placebos
Psychiatric Status Rating Scales
Quinolones - adverse effects; therapeutic use
Sleep Initiation and Maintenance Disorders - chemically induced
Treatment Outcome

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

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