At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 377 enrolled
Drug / intervention
Lurasidonedrug
Likely dose
Lurasidone 80 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 Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder
In Brief
A Phase 3 clinical trial evaluating Lurasidone for Bipolar I Disorder. Completed, enrolled 377 participants across 71 sites in 12 countries.
Detailed Summary
This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder
CountriesArgentina, Bulgaria, Chile, Czechia, France, Hungary, Japan, Poland, Russia, Serbia, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartJun 2012
Primary CompletionJul 2015
TodayJul 2026
First PostedApr 11, 2012
Enrollment StartJun 1, 2012
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.2 years ago
Interventions
Lurasidonedrug
Lurasidone 20-80 mg taken orally once daily