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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Cariprazine; Drug: Risperidone

• Registration Number: NCT00694707
• Lead Sponsor: Forest Laboratories

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Study Start: 2008-06-30
• Primary Completion: 2009-08-31
• Study Completion: 2009-08-31
• Disposition First Submitted: 2012-03-02
• Disposition First Submitted QC: 2012-03-02
• Disposition First Posted: 2012-03-06
• Status Verified: 2019-05
• Results First Submitted: 2019-05-17
• Results First Submitted QC: 2019-05-17
• Last Update Submitted: 2019-05-17
• Results First Posted: 2019-06-12
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 732

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.

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Exclusion Criteria

• Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
• First episode of psychosis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received placebo orally once a day for 6 weeks.
Cariprazine 1.5 mg	Cariprazine	Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
Risperidone 4.0 mg	Risperidone	Participants received risperidone 4.0 mg orally once a day for 6 weeks.
Cariprazine 3.0 mg	Cariprazine	Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
Cariprazine 4.5 mg	Cariprazine	Participants received cariprazine 4.5 mg orally once a day for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 6 in the PANSS Total Score	Baseline to Week 6	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 6 in the CGI-S Score	Baseline to Week 6	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.

Trial Locations

Locations (4)

Forest Investigative Site 1; 🇷🇺 Moscow, Russian Federation

Forest Investigative Site; 🇺🇦 Kiev, Ukraine

Forest Investigative Site 2; 🇷🇺 St. Petersburg, Russian Federation

Forest Investigative Site1; 🇷🇺 St. Petersburg, Russian Federation