Phase 3
N=765
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01412060 ↗Enrolled (actual)
765
Serious AEs
4.5%
Results posted
Jul 2018
Primary outcome: Primary: Time From Baseline to the First Symptom Relapse During the Double-blind Phase — 92; 224 Days — p=0.0010
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Cariprazine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Baseline to the First Symptom Relapse During the Double-blind Phase |
92; 224 | 0.0010 sig |
Summary
The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.
Eligibility Criteria
Inclusion Criteria
- Participants who have provided informed consent prior to any study specific procedures.
- Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.
- Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
- Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
- Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
- Body mass index between 18 and 40 kg/m^2, inclusive.
Exclusion Criteria
- Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
- Participants in their first episode of psychosis.
- Treatment-resistant schizophrenia over the last 2 years.
- Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
- At imminent risk of injuring self or others or causing significant damage to property.
- Suicide risk.
Data sourced from ClinicalTrials.gov (NCT01412060). 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.