Lurasidone Extended Use Study

Sumitomo Pharma

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Bipolar Disorder

Treatments

Drug: Lurasidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01485640

2011-000682-12 (EudraCT Number)

D1050298

Details and patient eligibility

About

This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

Enrollment

162 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required.
The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone

Exclusion criteria

The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior.
The subject resides in a country where lurasidone has been approved for any indication.
The subject is currently enrolled in any other investigational study.
The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).