Phase 3
N=446
Safety and Efficacy of Cariprazine in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01104779 ↗Enrolled (actual)
446
Serious AEs
5.2%
Results posted
Nov 2018
Primary outcome: Primary: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score — -16.0; -22.8; -25.9 Units on a Scale — p=0.0029
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cariprazine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score |
-16.0; -22.8; -25.9 | 0.0029 sig |
| SECONDARY Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S) |
-1.0; -1.4; -1.6 | 0.0115 sig |
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.
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)
- Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
- Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
Exclusion Criteria
- Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
- Patients in their first episode of psychosis
- Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
- Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
- Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
- Substance abuse or dependence within the prior 3 months
Data sourced from ClinicalTrials.gov (NCT01104779). 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.