Lurasidone Extended Use Study

Study Overview
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Brief Summary
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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.

Official Title
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A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

Conditions
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Schizophrenia, Bipolar Disorder

Intervention / Treatment
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* Drug: Lurasidone


Participation Criteria
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Eligibility Criteria
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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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasidone<br>Lurasidone flexibly dosed | Drug: Lurasidone<br>* Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs | Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S | The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, bipolar disorder, Lurasidone, Latuda