NCT00868699

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 505 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	lurasidone	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
DRUG	lurasidone	lurasidone 20 mg/day for Days 1-7
DRUG	Placebo	Placebo Comparator

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-03-25
• Last updated: 2014-04-17
• Results posted: 2013-07-02

Locations

55 sites across 8 countries: United States, Czechia, France, India, Romania, Russia, South Africa, Ukraine