A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia

Study Overview
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Brief Summary
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This is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine XR.

Official Title
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A Phase 3 Randomized, Double-Blind, Active-controlled Study to Evaluate the Efficacy and Safety of Lurasidone in Acutely Psychotic Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Lurasidone HCL 160 mg
* Drug: Quetiapine XR 600 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent and aged between 19 and 75 years of age. Meets DSM-5 criteria for a primary diagnosis of schizophrenia. CGI-S ≥ 4 at screening and baseline. Subject is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study. Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study. Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening. Exclusion Criteria: The subject has evidence of any chronic organic disease of the CNS (other than schizophrenia) Subject has participated in a prior trial of lurasidone. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months. In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

Ages Eligible for Study
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Minimum Age: 19 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: Lurasidone HCL 160 mg<br>Lurasidone HCL 160 mg/day | Drug: Lurasidone HCL 160 mg<br>* Lurasidone HCL 2 80mg tablets, QD<br>|
| Active Comparator: Quetiapine XR 600 mg<br>Quetiapine XR 600 mg/day | Drug: Quetiapine XR 600 mg<br>* Quetiapine XR 2 300 mg tablets, QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Total PANSS Score From Baseline at Week 6 | The PANSS (Positive and Negative Syndrome Scale) 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. | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in CGI-S score From Baseline at Week 6 | 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). | Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Acutely Psychotic Patients with Schizophrenia, Latuda, Lurasidone