A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

• Status: Completed
• Trial end date: 2010-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Gedeon Richter Ltd.
• Treatments: Cariprazine

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).