Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

Completed · Phase 2 · Has a placebo group

Conditions studied: Bipolar Depression

In brief

The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.

Key facts

Study ID

NCT00852202

Run by

Forest Laboratories

People needed

234

Starts

2009-06-30

Expected to finish

2010-06-15

Last updated by the study team

2018-08-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women, 18-65 years old
• Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic features, with a current depressive episode
• A verified previous manic, hypomanic, or mixed episode
• Score of 20 or higher on the HAMD-17
• Score of 2 or higher on Item 1 of the HAMD

You may not qualify if…

• Score greater than 12 on the Young Mania Rating Scale
• Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to Visit 1
• Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or specific phobias is acceptable)

Where it is running

• Forest Investigative Site 005 — Encino, California, United States
• Forest Investigative Site 017 — Garden Grove, California, United States
• Forest Investigative Site 027 — National City, California, United States
• Forest Investigative Site 013 — Newport Beach, California, United States
• Forest Investigative Site 010 — Oceanside, California, United States
• Forest Investigative Site 020 — Bradenton, Florida, United States
• Forest Investigative Site 007 — Jacksonville, Florida, United States
• Forest Investigative Site 019 — Kissimmee, Florida, United States
• Forest Investigative Site 026 — Orlando, Florida, United States
• Forest Investigative Site 012 — West Palm Beach, Florida, United States
• Forest Investigative Site 024 — Glen Burnie, Maryland, United States
• Forest Investigative Site 029 — Creve Coeur, Missouri, United States
• Forest Investigative Site 002 — Omaha, Nebraska, United States
• Forest Investigative Site 028 — Cherry Hill, New Jersey, United States
• Forest Investigative Site 001 — The Bronx, New York, United States
• Forest Investigative Site 018 — Durham, North Carolina, United States
• Forest Investigative Site 004 — Dayton, Ohio, United States
• Forest Investigative Site 022 — Mason, Ohio, United States
• Forest Investigative Site 015 — Portland, Oregon, United States
• Forest Investigative Site 006 — Media, Pennsylvania, United States
• Forest Investigative Site 011 — Philadelphia, Pennsylvania, United States
• Forest Investigative Site 014 — Nashville, Tennessee, United States
• Forest Investigative Site 023 — Irving, Texas, United States
• Forest Investigative Site 003 — Woodstock, Vermont, United States
• Forest Investigative Site 009 — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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