At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 356 enrolled
Drug / intervention
Lurasidone +1 moredrug
Likely dose
Lurasidone 120 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 Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.
In Brief
A Phase 3 clinical trial evaluating Lurasidone and Placebo for Bipolar Depression. Completed, enrolled 356 participants across 75 sites in 10 countries.
Detailed Summary
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesCanada, Colombia, Czechia, India, Japan, Lithuania, Peru, Slovakia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedJan 2011
Primary CompletionAug 2012
TodayJul 2026
First PostedJan 27, 2011
Enrollment StartNov 1, 2010
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.4 years ago
Interventions
Lurasidonedrug
Tablets 20-120 mg, PM dosing,daily for 6 weeks
Placebodrug
Equivalent to Lurasidone dosing