Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

Study Overview
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Brief Summary
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This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Official Title
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Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Placebo
* Drug: Cariprazine
* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 to 60 years of age. Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID). Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120. Diagnosis of schizophrenia for at least 1 year. Exclusion Criteria: Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values. First episode of psychosis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants received placebo orally once a day for 6 weeks. | Drug: Placebo<br>* Placebo was supplied in capsules.<br>|
| Experimental: Cariprazine 1.5 mg<br>Participants received cariprazine 1.5 mg orally once a day for 6 weeks. | Drug: Cariprazine<br>* Cariprazine was supplied in capsules<br>* Other names: RGH-188;|
| Experimental: Cariprazine 3.0 mg<br>Participants received cariprazine 3.0 mg orally once a day for 6 weeks. | Drug: Cariprazine<br>* Cariprazine was supplied in capsules<br>* Other names: RGH-188;|
| Experimental: Cariprazine 4.5 mg<br>Participants received cariprazine 4.5 mg orally once a day for 6 weeks. | Drug: Cariprazine<br>* Cariprazine was supplied in capsules<br>* Other names: RGH-188;|
| Active Comparator: Risperidone 4.0 mg<br>Participants received risperidone 4.0 mg orally once a day for 6 weeks. | Drug: Risperidone<br>* Risperidone was supplied in capsules<br>* Other names: Risperdal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 6 in the PANSS Total Score | The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement. | Baseline to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 6 in the CGI-S Score | The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement. | Baseline to Week 6 |