Status:
COMPLETED
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Gedeon Richter Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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.
Detailed Description
There were 3 periods (phases) in the study. The Open-label Phase lasted 20 weeks. In the first 6 weeks, participants received 3, 6, or 9 mg cariprazine orally once a day; the dose could be modified du...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2014
Estimated Enrollment :
765 Patients enrolled
Trial Details
Trial ID
NCT01412060
Start Date
September 27 2011
End Date
September 3 2014
Last Update
July 6 2018
Active Locations (73)
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1
Forest Investigative Site 011
Little Rock, Arkansas, United States, 72211
2
Forest Investigative Site 018
Cerritos, California, United States, 90703
3
Forest Investigative Site 007
Costa Mesa, California, United States, 92626
4
Forest Investigative Site 026
Culver City, California, United States, 90230