drugset / Trial / NCT00606177

A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

NCT00606177

Phase 3 Completed 99 enrolled Otsuka Pharmaceutical Co., Ltd.
Non-randomizedParallel-groupQuadruple-blindTreatment

Summary

To investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter "Study 003") in a double-blind manner to those patients who complete Study 003 and demonstrate drug efficacy.

Timeline

Start
2008-01
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Aripiprazole Other / unclassified 24 mg Oral

Indications