A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

Study Overview
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Brief Summary
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This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Official Title
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A Long-term, Open-label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Cariprazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have completed the double-blind treatment period of the lead-in study RGH-MD-16 (NCT 00694707) Patients who have responded to double-blind treatment in the lead-in study as defined as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S) score of ≤ 3. Patients eligible to continue as outpatients based on the opinion of the Principal Investigator. Patients must have a caregiver to ensure treatment compliance. Exclusion Criteria: Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 61 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cariprazine 1.5mg<br>Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability | Drug: Cariprazine<br>* Cariprazine was supplied in capsules.<br>* Other names: RGH-188;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 48 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 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 48 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 48 |