Phase 3
Completed N=617
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01104766 ↗Enrolled (actual)
617
Serious AEs
2.8%
Results posted
Oct 2018
Primary outcomePrimary: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. — -14.3; -20.2; -23.0; -21.2 Units on a Scale — p=0.0044
◆ Published Evidence
Highly cited
168citations · ~15 / year
Cariprazine in acute exacerbation of schizophrenia: a fixed-dose, phase 3, randomized, double-blind, placebo- and active-controlled trial.
Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
Linked Publications (5)
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Cariprazine in acute exacerbation of schizophrenia: a fixed-dose, phase 3, randomized, double-blind, placebo- and active-controlled trial.
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Evaluation of the long-term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-year open-label study.
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Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: Pooled analyses from 3 phase II/III studies.
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Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies.
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Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. |
-14.3; -20.2; -23.0; -21.2 | 0.0044 sig |
| SECONDARY Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S) |
-1.0; -1.4; -1.5; -1.4 | 0.0004 sig |
Eligibility Criteria
Inclusion Criteria
- Patients who have provided informed consent 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/ or electrocardiogram (ECG)
- Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1
- Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
- CGI-S score ≥ 4
Exclusion Criteria
- Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
- Bipolar I and II disorder
- Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
- DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
- Women who are pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT01104766) 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.