A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

Phase 4 Completed 1270 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

Timeline

Start: 2005-09
Primary completion: 2009-06
Completion: 2009-10

Outcome

Met primary endpoint

paper ARI+Li / Val significantly delayed time to any relapse compared with PLB+Li / Val; hazard ratio=0.54 (95% confidence interval: 0.33-0.89; log-rank p=0.014. PMID 21443567 ↗

Publications

Marcus R, Khan A, Rollin L, Morris B, Timko K, Carson W, Sanchez R. Efficacy of aripiprazole adjunctive to lithium or valproate in the long-term treatment of patients with bipolar I disorder with an inadequate response to lithium or valproate monotherapy: a multicenter, double-blind, randomized study. Bipolar Disord. 2011 Mar;13(2):133-44. doi: 10.1111/j.1399-5618.2011.00898.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aripiprazole	Other / unclassified	—	Oral
Background	Lithium	Unknown	—	Oral
Background	Valproate	Small molecule	—	Oral