Phase 2 Completed N=732 Randomized Double-blind Treatment

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

Schizophrenia

Source: ClinicalTrials.gov NCT00694707 ↗

Enrolled (actual)

732

Serious AEs

2.6%

Results posted

Jun 2019

Primary outcomePrimary: Change From Baseline to Week 6 in the PANSS Total Score — 97.3; 97.1; 97.2; 96.7 Units on a scale — p=0.0005

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 6 in the PANSS Total Score	97.3; 97.1; 97.2; 96.7; 98.1; -9.5	0.0005 sig
SECONDARY Change From Baseline to Week 6 in the CGI-S Score	4.9; 4.7; 4.9; 4.8; 4.8; -0.6	0.0040 sig

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00694707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.