Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

Completed · Phase 3

Conditions studied: Bipolar I Disorder

In brief

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

Key facts

Study ID

NCT01059539

Run by

Forest Laboratories

People needed

403

Starts

2010-02-28

Expected to finish

2012-02-29

Last updated by the study team

2019-06-13

Who can join

Age: 18 and older, up to 65. 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 bipolar I disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
• Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
• Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

You may not qualify if…

• Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.

Where it is running

• Forest Investigative Site 015 — Springdale, Arkansas, United States
• Forest Investigative Site 010 — Carson, California, United States
• Forest Investigative Site 020 — Cerritos, California, United States
• Forest Investigative Site 009 — Escondido, California, United States
• Forest Investigative Site 004 — Garden Grove, California, United States
• Forest Investigative Site 016 — San Diego, California, United States
• Forest Investigative Site 007 — Santa Ana, California, United States
• Forest Investigative Site 023 — Washington D.C., District of Columbia, United States
• Forest Investigative Site 001 — Bradenton, Florida, United States
• Forest Investigative Site 006 — Fort Lauderdale, Florida, United States
• Forest Investigative Site 013 — Kissimmee, Florida, United States
• Forest Investigative Site 021 — Rockville, Maryland, United States
• Forest Investigative Site 024 — Flowood, Mississippi, United States
• Forest Investigative Site 022 — Creve Coeur, Missouri, United States
• Forest Investigative Site 003 — Saint Charles, Missouri, United States
• Forest Investigative Site 025 — St Louis, Missouri, United States
• Forest Investigative Site 012 — Las Vegas, Nevada, United States
• Forest Investigative Site 002 — Willingboro, New Jersey, United States
• Forest Investigative Site 005 — Cincinnati, Ohio, United States
• Forest Investigative Site 011 — Oklahoma City, Oklahoma, United States
• Forest Investigative Site 017 — Austin, Texas, United States
• Forest Investigative Site 014 — Austin, Texas, United States
• Forest Investigative Site 018 — DeSoto, Texas, United States
• Forest Investigative Site 019 — Houston, Texas, United States
• Forest Investigative Site 309 — Gyula, Bekes County, Hungary

Full record on ClinicalTrials.gov

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