NCT01566162

A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

Detailed description

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Lurasidone	Lurasidone 40-80 mg taken orally taken once daily

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-03-29
• Last updated: 2019-04-09
• Results posted: 2014-11-20

Locations

63 sites across 7 countries: United States, France, Italy, Russia, Serbia, Slovakia, South Africa