A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
Completed · Phase 3 · Has a placebo group
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT01412060
- Run by
- Forest Laboratories
- People needed
- 765
- Starts
- 2011-09-27
- Expected to finish
- 2014-09-03
- Last updated by the study team
- 2018-07-06
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Forest Investigative Site 018 — Cerritos, California, United States
- Forest Investigative Site 007 — Costa Mesa, California, United States
- Forest Investigative Site 026 — Culver City, California, United States
- Forest Investigative Site 008 — Long Beach, California, United States
- Forest Investigative Site 002 — Oceanside, California, United States
- Forest Investigative Site 019 — Orange, California, United States
- Forest Investigative Site 001 — Paramount, California, United States
- Forest Investigative Site 020 — San Diego, California, United States
- Forest Investigative Site 005 — Washington D.C., District of Columbia, United States
- Forest Investigative Site 024 — Leesburg, Florida, United States
- Forest Investigative Site 017 — Atlanta, Georgia, United States
- Forest Investigative Site 021 — Chicago, Illinois, United States
- Forest Investigative Site 023 — Baltimore, Maryland, United States
- Forest Investigative Site 010 — Rockville, Maryland, United States
- Forest Investigative Site 003 — Flowood, Mississippi, United States
- Forest Investigative Site 006 — Creve Coeur, Missouri, United States
- Forest Investigative Site 014 — St Louis, Missouri, United States
- Forest Investigative Site 012 — Cedarhurst, New York, United States
- Forest Investigative Site 022 — Dayton, Ohio, United States
- Forest Investigative Site 015 — Austin, Texas, United States
- Forest Investigative Site 027 — Austin, Texas, United States
- Forest Investigative Site 025 — Dallas, Texas, United States
- Forest Investigative Site 013 — Houston, Texas, United States
- Forest Investigative Site 009 — Houston, Texas, United States
- Forest Investigative Site 011 — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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