Conditions: Schizophrenia
Keywords: Lurasidone Latuda Schizophrenia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 191
Healthy volunteers: no

Brief 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

Arms:
arm 1: Lurasidone 40 - 80mg flexible dose

Interventions: intervention 1: Lurasidone
Intervention descriptions: intervention 1: Lurasidone 40-80 mg taken orally taken once daily

Protocol document: