Phase 3 N=752 Treatment

Long-term Study of Cariprazine in Patients With Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT01104792 ↗

Enrolled (actual)

752

Serious AEs

10.1%

Results posted

Jul 2019

Primary outcome: Primary: Change From Baseline to Week 48 in the PANSS Total Score — 66.5; -5.0 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Cariprazine (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Forest Laboratories
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 48 in the PANSS Total Score	66.5; -5.0	—
SECONDARY Change From Baseline to Week 48 in the CGI-S Score	3.0; -0.1	—

Summary

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Eligibility Criteria

Inclusion Criteria

Patients and corresponding caregivers who have provided informed consents prior to any study specific procedures.
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01104792). 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.