DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A comparison of two fixed doses of aripiprazole with placebo in acutely relapsed, hospitalized patients with bipolar disorder I (manic or mixed) in subpopulations (CN138-007).

Author(s): El Mallakh RS, Vieta E, Rollin L, Marcus R, Carson WH, McQuade R

Affiliation(s): Department of Psychiatry and Behavioral Sciences, University of Louisville, Louisville, KY 40292, USA. rselma01@louisville.edu

Publication date & source: 2010-11, Eur Neuropsychopharmacol., 20(11):776-83. Epub 2010 Aug 21.

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

This study evaluated the efficacy and safety of two fixed doses of aripiprazole (15 mg/day, n = 131 and 30 mg/day, n = 136) compared with placebo (n = 134) in acutely manic or mixed bipolar I hospitalized patients. The mean change from baseline to Week 3 in the YMRS Total Scores was -10.01 (95% CI: -11.92, -8.09) for aripiprazole 15 mg/day, -10.80 (95% CI: -12.71, -8.90) for aripiprazole 30 mg/day, and -10.12 (95% CI: -12.01, -8.24) for placebo. The most frequent adverse events (> or = 10% and greater than placebo) for either of the aripiprazole treatment groups were headache, nausea, dyspepsia, insomnia, agitation, constipation, akathisia, anxiety, lightheadedness, vomiting, diarrhea, asthenia and extremity pain. Aripiprazole 15 or 30 mg/day was not significantly more effective than placebo in the treatment of bipolar I disorder acute mania at endpoint (Week 3). A high placebo response rate may have accounted for the lack of separation between treatment groups. Copyright (c) 2010 Elsevier B.V. All rights reserved.

Page last updated: 2011-12-09

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017