Safety and Efficacy of Cariprazine in Schizophrenia
Completed · Phase 3 · Has a placebo group
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT01104779
- Run by
- Forest Laboratories
- People needed
- 446
- Starts
- 2010-04-27
- Expected to finish
- 2011-12-15
- Last updated by the study team
- 2018-11-14
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Forest Investigative Site 48 — Costa Mesa, California, United States
- Forest Investigative Site 50 — Long Beach, California, United States
- Forest Investigative Site 42 — Paramount, California, United States
- Forest Investigative Site 054 — San Diego, California, United States
- Forest Investigative Site 41 — Kissimmee, Florida, United States
- Forest Investigative Site 055 — Atlanta, Georgia, United States
- Forest Investigative Site 44 — Rockville, Maryland, United States
- Forest Investigative Site 45 — St Louis, Missouri, United States
- Forest Investigative Site 52 — Las Vegas, Nevada, United States
- Forest Investigative Site 40 — Cedarhurst, New York, United States
- Forest Investigative Site 46 — Cincinnati, Ohio, United States
- Forest Investigative Site 47 — Philadelphia, Pennsylvania, United States
- Forest Investigative 49 — Memphis, Tennessee, United States
- Forest Investigative Site 51 — Houston, Texas, United States
- Forest Investigative Site 43 — Irving, Texas, United States
- Forest Investigative Site 601 — Bello, Antioquia, Colombia
- Forest Investigative Site 604 — Pereira, Risaralda Department, Colombia
- Forest Investigative Site 602 — Bogotá, Colombia
- Forest Investigative Site 605 — Bogotá, Colombia
- Forest Investigative Site 505 — Vijayawada, Andhra Pradesh, India
- Forest Investigative Site 514 — Visakhapatnam, Andhra Pradesh, India
- Forest Investigative Site 503 — Ahmedabad, Gujarat, India
- Forest Investigative Site 519 — Ahmedabad, Gujarat, India
- Forest Investigative Site 501 — Ahmedabad, Gujarat, India
- Forest Investigative Site 508 — Ahmedabad, Gujarat, India
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.