NCT00606320

A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of long-term administration of aripiprazole by performing extended administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner to those patients who completed 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") but whose condition worsened or remained unchanged or who discontinued Study 003 between Day 14 and Day 21 due to lack of drug efficacy.

Conditions

• Bipolar I Disorder

Interventions

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