At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 493 enrolled
Drug / intervention
Aripiprazole +3 moredrug
Likely dose
Placebo 0 mgfrom 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 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Apr 23, 2008·Updated Dec 2, 2013
In Brief
A Phase 3 clinical trial evaluating Aripiprazole, Placebo, and 2 other interventions for Bipolar Disorder Mania. Completed, enrolled 493 participants across 73 sites in 13 countries.
Detailed Summary
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder Mania
CountriesAustria, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Romania, Russia, South Africa, Spain, Turkey (Türkiye)
CollaboratorsOtsuka America Pharmaceutical
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartJun 2008
Primary CompletionOct 2011
TodayJul 2026
First PostedApr 23, 2008
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.2 years ago
Interventions
Aripiprazoledrug
5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks
Placebodrug
Tablets, Oral, 0 mg, once daily, 12 weeks
Lithiumdrug
Participant's ongoing dose
Valproatedrug
Participant's ongoing dose