NCT01358357

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

A Randomized, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 965 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

Detailed description

This study is to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and/or psychotic features.

Conditions

• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	Lurasidone	Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
DRUG	Placebo	20-80 mg flexible dose

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2011-05-23
• Last updated: 2016-09-07
• Results posted: 2016-07-26

Locations

105 sites across 14 countries: United States, Argentina, Australia, Bulgaria, Chile, Croatia, Czechia, France, Hungary, Japan, Poland, Russia, Serbia, Slovakia