Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia

Study Overview
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Brief Summary
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Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.

Official Title
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Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Lurasidone HCl
* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: To be eligible to enter the study, each patient must comply with the following inclusion criteria: Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment). Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes. Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study. Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator. Subject voluntarily agrees to participate in the study by giving written informed consent. Main Exclusion Criteria: To be excluded from entering this study if they fulfil any of the criteria below: Subject has a chronic organic disease of the central nervous system (other than schizophrenia). Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months. In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study. Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lurasidone | Drug: Lurasidone HCl<br>* 40 - 120mg per day<br>|
| Active Comparator: 2<br>Risperidone | Drug: Risperidone<br>* Risperidone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events. |  | 12 months | 

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