At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 41 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.
A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
In Brief
A Phase 3 clinical trial evaluating Aripiprazole for Bipolar I Disorder. Completed, enrolled 41 participants across 5 sites.
Detailed Summary
To assess the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I Disorder experiencing a manic or mixed episode
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder
CountriesJapan
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