Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

Completed · Phase 2 · Has a placebo group

Conditions studied: Depression, Bipolar

In brief

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

Key facts

Study ID

NCT01396447

Run by

Forest Laboratories

People needed

584

Starts

2011-07-26

Expected to finish

2014-01-10

Last updated by the study team

2018-05-01

Who can join

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

You may qualify if…

• Participants who have provided informed consent prior to any study specific procedures.
• Participants 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 (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
• Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
• Verified previous manic or mixed episode.
• Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
• Participants with a HAMD-17 item 1 score ≥ 2.
• Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

You may not qualify if…

• Participants 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 6 months.
• Women who are pregnant or breast feeding
• Participants with Young Mania Rating Scale (YMRS) total score > 10
• Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.

Where it is running

• Forest Investigative Site 017 — Springdale, Arkansas, United States
• Forest Investigative Site 030 — Beverly Hills, California, United States
• Forest Investigative Site 018 — Cerritos, California, United States
• Forest Investigative Site 028 — Costa Mesa, California, United States
• Forest Investigative Site 015 — Oceanside, California, United States
• Forest Investigative Site 011 — Temecula, California, United States
• Forest Investigative Site 012 — Jacksonville, Florida, United States
• Forest Investigative Site 035 — Orlando, Florida, United States
• Forest Investigative Site 013 — Winter Park, Florida, United States
• Forest Investigative Site 038 — Atlanta, Georgia, United States
• Forest Investigative Site 005 — Atlanta, Georgia, United States
• Forest Investigative Site 029 — Chicago, Illinois, United States
• Forest Investigative Site 024 — Indianapolis, Indiana, United States
• Forest Investigative Site 031 — Prairie Village, Kansas, United States
• Forest Investigative Site 041 — Lake Charles, Louisiana, United States
• Forest Investigative Site 040 — Shreveport, Louisiana, United States
• Forest Investigative Site 039 — Flowood, Mississippi, United States
• Forest Investigative Site 026 — Creve Coeur, Missouri, United States
• Forest Investigative Site 037 — Las Vegas, Nevada, United States
• Forest Investigative Site 023 — Cherry Hill, New Jersey, United States
• Forest Investigative Site 014 — Marlton, New Jersey, United States
• Forest Investigative Site 006 — Albuquerque, New Mexico, United States
• Forest Investigative Site 003 — Brooklyn, New York, United States
• Forest Investigative Site 025 — New York, New York, United States
• Forest Investigative Site 021 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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