Phase 2 N=93 Treatment

A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00839852 ↗

Enrolled (actual)

Serious AEs

12.9%

Results posted

Aug 2019

Primary outcome: Primary: Change From Baseline to Week 48 in the PANSS Total Score — -38.5 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cariprazine (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Forest Laboratories
Primary completion: Aug 2010

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	—

Summary

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

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).

View full record on ClinicalTrials.gov →

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.