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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	oral, 24mg(4 tablets)/day
DRUG	placebo	oral, 0mg(4tablets)/day

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-02-01
• Last updated: 2014-02-12
• Results posted: 2014-02-12

Locations

12 sites across 4 countries: China, Japan, South Korea, Taiwan