Phase 2
Completed N=93
A Study of Cariprazine in Patients With Chronic Stable Schizophrenia
Source: ClinicalTrials.gov NCT00839852 ↗Enrolled (actual)
93
Serious AEs
12.9%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline to Week 48 in the PANSS Total Score — -38.5 Units on a scale
Summary
This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 48 in the PANSS Total Score |
-38.5 | — |
| SECONDARY Change From Baseline to Week 48 in the CGI-S Score |
-2.0 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00839852). 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.