At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 258 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.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group-Comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
In Brief
A Phase 3 clinical trial evaluating Aripiprazole and placebo for Bipolar I Disorder. Completed, enrolled 258 participants across 12 sites in 4 countries.
Detailed Summary
The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder
CountriesChina, Japan, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedFeb 2008
Primary CompletionNov 2010
TodayJul 2026
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/day
placebodrug
oral, 0mg(4tablets)/day