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 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-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Lurasidone
* Drug: Olanzapine
* Drug: Placebo comparator
* Drug: Lurasidone 40 mg tablets


Participation Criteria
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Eligibility Criteria
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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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasdione 40mg tablets<br> | Drug: Lurasidone 40 mg tablets<br>* Lurasidone 40 mg tablets<br>|
| Experimental: 120mg<br> | Drug: Lurasidone<br>* 120mg/day<br>|
| Active Comparator: 15mg Olz<br> | Drug: Olanzapine<br>* 15mg/day<br>|
| Placebo Comparator: Sugar pill<br> | Drug: Placebo comparator<br>* Placebor Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period. | The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment. | The CGI-S 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. | 6 weeks | 

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