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

Sumitomo Pharma

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Lurasidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01566162

2011-004790-90 (EudraCT Number)

D1050307

Details and patient eligibility

About

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.

Full 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

Enrollment

191 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has agreed to participate by providing written informed consent.
Subject will be eligible to participate if one of the following criteria is met:
Subject has completed the 28-week double-blind phase of study D1050238
Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238
Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.
Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238.
Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion criteria

Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.