CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,270 enrolled
Drug / intervention
Lithium or Valproate with placebo (PBO) +1 moredrug
Likely dose
Lithium or Valproate with placebo (PBO) 2100 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.

Search/NCT00261443
NCT00261443Phase 4Completed
CompareCT.gov

Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Dec 5, 2005·Updated Apr 18, 2023

In Brief

A Phase 4 clinical trial evaluating Lithium or Valproate with placebo (PBO) and Lithium or Valproate with Aripiprazole for Bipolar Disorder. Completed, enrolled 1,270 participants across 83 sites in 9 countries.

Detailed Summary

The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesBrazil, Bulgaria, Croatia, Czechia, France, India, Russia, South Africa, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2005
Enrollment StartSep 1, 2005
Primary CompletionJun 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.6 years ago

Interventions

Lithium or Valproate with placebo (PBO)drug

Tablets, Oral, once daily lithium 250-2100 mg/day valproate 250-2500mg/day Placebo once daily

Lithium or Valproate with Aripiprazoledrug

Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks) lithium 250-2100 mg/day valproate 250-2500mg/day aripiprazole 15-30 mg/day