Status:
COMPLETED
A Study of Cariprazine in Patients With Chronic Stable Schizophrenia
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Gedeon Richter Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-61 years
Phase:
PHASE2
Brief Summary
This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
Eligibility Criteria
Inclusion
- 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
- Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
Key Trial Info
Start Date :
May 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2010
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00839852
Start Date
May 31 2009
End Date
August 31 2010
Last Update
August 22 2019
Active Locations (65)
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1
Forest Investigative Site
Costa Mesa, California, United States, 92626
2
Forest Investigative Site
Long Beach, California, United States, 90813
3
Forest Investigative Site
Oceanside, California, United States, 92056
4
Forest Investigative Site
Paramount, California, United States, 90723