At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 505 enrolled
Drug / intervention
lurasidone +2 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, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
In Brief
A Phase 3 clinical trial evaluating lurasidone and Placebo for Bipolar Depression. Completed, enrolled 505 participants across 55 sites in 8 countries.
Detailed Summary
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesCzechia, France, India, Romania, Russia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartApr 2009
Primary CompletionFeb 2012
TodayJul 2026
First PostedMar 25, 2009
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.3 years ago
Interventions
lurasidonedrug
lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
lurasidonedrug
lurasidone 20 mg/day for Days 1-7
Placebodrug
Placebo Comparator