A Study of Cariprazine in Patients With Chronic Stable Schizophrenia (NCT00839852) | Clinical Trial Compass
CompletedPhase 2
A Study of Cariprazine in Patients With Chronic Stable Schizophrenia
United States97 participantsStarted 2009-05-31
Plain-language summary
This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
Who can participate
Age range18 Years – 61 Years
SexALL
See this in plain English?
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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).
What they're measuring
1
Change From Baseline to Week 48 in the PANSS Total Score