CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 59 enrolled
Drug / intervention
Aripiprazoledrug
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/NCT00606320
NCT00606320Phase 3Completed
CompareCT.gov

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

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

In Brief

A Phase 3 clinical trial evaluating Aripiprazole for Bipolar I Disorder. Completed, enrolled 59 participants across 12 sites in 4 countries.

Detailed 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.

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