A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

Phase 2

Completed

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

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Cariprazine 1.5mg	Cariprazine	Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 48 in the PANSS Total Score	Baseline to Week 48	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 48 in the CGI-S Score	Baseline to Week 48	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.

Locations (8): Forest Investigative Site 214
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St. Petersburg, Russian Federation
Forest Investigative Site 202
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St. Petersburg, Russian Federation
Forest Investigative Site 203
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St. Petersburg, Russian Federation
Forest Investivative Site
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Kharkiv, Ukraine
Forest Investigative Site 204
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Moscow, Russian Federation
Forest Investigative Site 206
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Moscow, Russian Federation
Forest Investigative Site
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Ternopil, Ukraine
Forest Investigative Site 217
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St. Petersburg, Russian Federation