NCT00868452

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (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 when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	lurasidone + (lithium or divalproex)	lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
DRUG	Placebo + (lithium or divalproex)	20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2009-03-25
• Last updated: 2014-04-17
• Results posted: 2013-04-02

Locations

71 sites across 10 countries: United States, Czechia, France, Germany, India, Poland, Romania, Russia, South Africa, Ukraine