A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents

Study Overview
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Brief Summary
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Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.

Official Title
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A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Lurasidone HCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject ≥ 18 years of age. Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder. Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns. Exclusion Criteria: Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening. Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening. Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasidone Open-Label Arm A<br> | Drug: Lurasidone HCl<br>* Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks<br>* Other names: Latuda;|
| Experimental: Lurasidone Open-Label Arm B<br> | Drug: Lurasidone HCl<br>* Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks<br>* Other names: Latuda;|
| Experimental: Lurasidone Open-Label Arm C<br> | Drug: Lurasidone HCl<br>* Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks<br>* Other names: Latuda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Relapse of Psychotic Symptoms During 6 Weeks | Relapse is defined as any occurrence of: Insufficient clinical response Exacerbation of underlying disease Discontinuation due to an adverse event | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and Safety | Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events | 6 Weeks | 

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