At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 965 enrolled
Drug / intervention
Lurasidone +1 moredrug
Likely dose
Lurasidone 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, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder
In Brief
A Phase 3 clinical trial evaluating Lurasidone and Placebo for Bipolar I Disorder. Completed, enrolled 965 participants across 105 sites in 14 countries.
Detailed Summary
This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder
CountriesArgentina, Australia, Bulgaria, Chile, Croatia, Czechia, France, Hungary, Japan, Poland, Russia, Serbia, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartJun 2011
Primary CompletionApr 2015
TodayJul 2026
First PostedMay 23, 2011
Enrollment StartJun 1, 2011
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.1 years ago
Interventions
Lurasidonedrug
Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
Placebodrug
20-80 mg flexible dose