Long-term Study of Cariprazine in Patients With Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Key facts

Study ID

NCT01104792

Run by

Forest Laboratories

People needed

752

Starts

2010-05-31

Expected to finish

2013-01-31

Last updated by the study team

2019-07-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients and corresponding caregivers who have provided informed consents 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 electrocardiogram (ECG).

You may not qualify if…

• Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.

Where it is running

• Forest Investigative Site 021 — Little Rock, Arkansas, United States
• Forest Investigative Site 086 — Little Rock, Arkansas, United States
• Forest Investigative Site 014 — Springdale, Arkansas, United States
• Forest Investigative Site 080 — Carson, California, United States
• Forest Investigative Site 079 — Cerritos, California, United States
• Forest Investigative Site 048 — Costa Mesa, California, United States
• Forest Investigative Site 070 — Costa Mesa, California, United States
• Forest Investigative Site 022 — Garden Grove, California, United States
• Forest Investigative Site 083 — Garden Grove, California, United States
• Forest Investigative Site 050 — Long Beach, California, United States
• Forest Investigative Site 006 — Oceanside, California, United States
• Forest Investigative Site 003 — Riverside, California, United States
• Forest Investigative Site 016 — San Diego, California, United States
• Forest Investigative Site 073 — Santa Ana, California, United States
• Forest Investigative Site 071 — New Britain, Connecticut, United States
• Forest Investigative Site 002 — Bradenton, Florida, United States
• Forest Investigative Site 041 — Kissimmee, Florida, United States
• Forest Investigative Site 082 — North Miami, Florida, United States
• Forest Investigative Site 055 — Atlanta, Georgia, United States
• Forest Investigative Site 087 — Atlanta, Georgia, United States
• Forest Investigative Site 012 — Honolulu, Hawaii, United States
• Forest Investigative Site 018 — Chicago, Illinois, United States
• Forest Investigative Site 008 — Hoffman Estates, Illinois, United States
• Forest Investigative Site 044 — Rockville, Maryland, United States
• Forest Investigative Site 072 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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