CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 99 enrolled
Drug / intervention
Aripiprazole +1 moredrug
Likely dose
Aripiprazole 24mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00606177
NCT00606177Phase 3Completed
CompareCT.gov

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

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Feb 1, 2008·Updated Feb 12, 2014

In Brief

A Phase 3 clinical trial evaluating Aripiprazole and placebo for Bipolar I Disorder. Completed, enrolled 99 participants across 12 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder
CountriesChina, Japan, South Korea, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 1, 2008
Enrollment StartJan 1, 2008
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.4 years ago

Interventions

Aripiprazoledrug

oral, 24mg(4 tablets)/day

placebodrug

oral, 0mg(4tablets)/day