NCT01284517

Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

A Randomized, 6-week Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Lurasidone	Tablets 20-120 mg, PM dosing,daily for 6 weeks
DRUG	Placebo	Equivalent to Lurasidone dosing

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-01-27
• Last updated: 2013-11-26
• Results posted: 2013-10-14

Locations

75 sites across 10 countries: United States, Canada, Colombia, Czechia, India, Japan, Lithuania, Peru, Slovakia, Ukraine