CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 817 enrolled
Drug / intervention
lurasidonedrug
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.

Search/NCT00868959
NCT00868959Phase 3Completed
CompareCT.gov

A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression

Sumitomo Pharma America, Inc.·interventional·Posted Mar 25, 2009·Updated Apr 14, 2016

In Brief

A Phase 3 clinical trial evaluating lurasidone for Bipolar Depression. Completed, enrolled 817 participants across 151 sites in 15 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
CountriesCanada, Colombia, Czechia, France, India, Japan, Lithuania, Peru, Poland, Romania, Russia, Slovakia, South Africa, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2009
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.3 years ago

Interventions

lurasidonedrug

Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks