Safety and Efficacy of Cariprazine in Patients With 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

NCT01104766

Run by

Forest Laboratories

People needed

617

Starts

2010-04-23

Expected to finish

2011-12-20

Last updated by the study team

2018-10-29

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)
• Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
• Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1
• Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
• CGI-S score ≥ 4

You may not qualify if…

• Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
• Bipolar I and II disorder
• Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
• DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
• Women who are pregnant or breast feeding

Where it is running

• Woodland Research Northwest, LLC — Springdale, Arkansas, United States
• Synergy Clinical Research of Escondido — Escondido, California, United States
• Excell Research, Inc — Oceanside, California, United States
• Clinical Innovations, Inc. — Riverside, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• Collaborative Neuroscience Network, Inc. — Torrance, California, United States
• Colorado Clinical Trials, Inc. — Littleton, Colorado, United States
• Comprehensive Clinical Development, Inc. — Washington D.C., District of Columbia, United States
• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• Hawaii Clinical Research Center — Honolulu, Hawaii, United States
• Uptown Research Institute, LLC — Chicago, Illinois, United States
• Alexian Brothers Center for Psychiatric Research — Hoffman Estates, Illinois, United States
• Precise Research Centers — Flowood, Mississippi, United States
• Millennium Psychiatric Associates, LLC — Creve Coeur, Missouri, United States
• CRI Worldwide, LLC — Willingboro, New Jersey, United States
• Windsor-Laurelwood Center for Behavioral Medicine — Willoughby, Ohio, United States
• Vanderbilt Psychiatric Hospital — Nashville, Tennessee, United States
• Claghorn-Lesem Research Clinic, Ltd. — Houston, Texas, United States
• Pacific Institute of Medical Sciences — Bothell, Washington, United States
• Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie — Bucharest, Romania
• Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie — Bucharest, Romania
• Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie — Bucharest, Romania
• Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III — Cluj-Napoca, Romania
• Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie — Craiova, Romania
• Woodland International Research Group, Inc. — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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