Lurasidone HCl: A Phase 3 Study of Patients With Acute 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 more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Official Title
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A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Lurasidone HCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible to enter the study, each patient must comply with the following inclusion criteria: Provide written informed consent and aged between 18 and 75 years of age. Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia. Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study. Able and agrees to remain off prior antipsychotic medication for the duration of study. Good physical health on the basis of medical history, physical examination, and laboratory screening. Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits. Exclusion Criteria: Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Any chronic organic disease of the CNS (other than schizophrenia) Used investigational compound within 30 days. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasidone 40mg<br> | Drug: Lurasidone HCl<br>* Once daily<br>|
| Experimental: Lurasidone 80mg<br> | Drug: Lurasidone HCl<br>* Once daily<br>|
| Experimental: Lurasidone 120mg<br> | Drug: Lurasidone HCl<br>* Once daily<br>|
| Placebo Comparator: Sugar Pill<br> | Drug: Lurasidone HCl<br>* Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total PANSS Score From Baseline to the End of the Double Blind Phase | The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-S From Baseline to the End of the Double-blind Treatment | Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill). | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, SM-13496, Latuda, Lurasidone