Phase 3
Completed N=752
Long-term Study of Cariprazine in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01104792 ↗Enrolled (actual)
752
Serious AEs
10.1%
Results posted
Jul 2019
Primary outcomePrimary: Change From Baseline to Week 48 in the PANSS Total Score — 66.5; -5.0 Units on a scale
◆ Published Evidence
Established
84citations · ~9 / year
The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis.
Summary
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
Linked Publications (3)
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The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis.
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Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety.
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Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies.
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01104792) and the linked publication. 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. Informational only — not medical advice.