At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 348 enrolled
Drug / intervention
lurasidone + (lithium or divalproex) +1 moredrug
Likely dose
lurasidone + (lithium or divalproex) 20 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 Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression
In Brief
A Phase 3 clinical trial evaluating lurasidone + (lithium or divalproex) and Placebo + (lithium or divalproex) for Bipolar Depression. Completed, enrolled 348 participants across 71 sites in 10 countries.
Detailed Summary
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesCzechia, France, Germany, India, Poland, Romania, Russia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartApr 2009
Primary CompletionDec 2011
Study CompletionJan 2012
TodayJul 2026
First PostedMar 25, 2009
Enrollment StartApr 1, 2009
Primary CompletionDec 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.3 years ago
Interventions
lurasidone + (lithium or divalproex)drug
lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
Placebo + (lithium or divalproex)drug
20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7