Safety and Efficacy of Cariprazine for Bipolar I Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Mania, Bipolar I Disorder

In brief

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Key facts

Study ID

NCT01058668

Run by

Forest Laboratories

People needed

497

Starts

2010-02-01

Expected to finish

2011-12-01

Last updated by the study team

2017-04-12

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) manic or mixed type with or without psychotic symptoms
• Voluntarily hospitalized for current manic episode
• 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 an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months

Where it is running

• Forest Investigative Site 012 — Cerritos, California, United States
• Forest Investigative Site 010 — Costa Mesa, California, United States
• Forest Investigative Site 005 — Oceanside, California, United States
• Forest Investigative Site 023 — San Diego, California, United States
• Forest Investigative Site 017 — San Diego, California, United States
• Forest Investigative Site 024 — Santa Ana, California, United States
• Forest Investigative Site 016 — New Britain, Connecticut, United States
• Forest Investigative Site 007 — Washington D.C., District of Columbia, United States
• Forest Investigative Site 002 — Kissimmee, Florida, United States
• Forest Investigative Site 003 — Orlando, Florida, United States
• Forest Investigative Site 026 — Atlanta, Georgia, United States
• Forest Investigative Site 013 — Honolulu, Hawaii, United States
• Forest Investigative Site 011 — Hoffman Estates, Illinois, United States
• Forest Investigative Site 021 — Greenwood, Indiana, United States
• Forest Investigative Site 001 — Shreveport, Louisiana, United States
• Forest Investigative Site 006 — Rockville, Maryland, United States
• Forest Investigative Site 025 — St Louis, Missouri, United States
• Forest Investigative Site 008 — Cedarhurst, New York, United States
• Forest Investigative Site 019 — Philadelphia, Pennsylvania, United States
• Forest Investigative Site 015 — Memphis, Tennessee, United States
• Forest Investigative Site 004 — Irving, Texas, United States
• Forest Investigative Site 014 — Bothell, Washington, United States
• Forest Investigative Site 607 — Rijeka, Croatia
• Forest Investigative Site 602 — Zagreb, Croatia
• Forest Investigative Site 018 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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