Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.

Key facts

Study ID

NCT01469377

Run by

Forest Laboratories

People needed

819

Starts

2011-12-15

Expected to finish

2013-12-12

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…

• Male or female outpatients 18 to 65 years of age, inclusive.
• Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
• Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
• Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

You may not qualify if…

• Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
• Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.
• History of meeting DSM-IV-TR criteria for:
• Depressive episode with psychotic or catatonic features.
• Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
• Schizophrenia, schizoaffective, or other psychotic disorder.
• Obsessive-compulsive disorder.
• Bulimia or anorexia nervosa.
• Dementia, amnesic, or other cognitive disorder.
• Mental retardation.
• Participants considered a suicide risk.

Where it is running

• Forest Investigative Site 019 — National City, California, United States
• Forest Investigative Site 039 — Oceanside, California, United States
• Forest Investigative Site 015 — Orange, California, United States
• Forest Investigative Site 050 — Orange, California, United States
• Forest Investigative Site 008 — Redlands, California, United States
• Forest Investigative Site 066 — Sherman Oaks, California, United States
• Forest Investigative Site 063 — Gainesville, Florida, United States
• Forest Investigative Site 029 — Jacksonville, Florida, United States
• Forest Investigative Site 012 — Kissimmee, Florida, United States
• Forest Investigative Site 023 — Miami, Florida, United States
• Forest Investigative Site 026 — Orlando, Florida, United States
• Forest Investigative Site 062 — Atlanta, Georgia, United States
• Forest Investigative Site 065 — Smyrna, Georgia, United States
• Forest Investigative Site 074 — Prairie Village, Kansas, United States
• Forest Investigative Site 040 — Flowood, Mississippi, United States
• Forest Investigative Site 068 — Creve Coeur, Missouri, United States
• Forest Investigative Site 061 — Cherry Hill, New Jersey, United States
• Forest Investigative Site 038 — Marlton, New Jersey, United States
• Forest Investigative Site 030 — Albuquerque, New Mexico, United States
• Forest Investigative Site 076 — Brooklyn, New York, United States
• Forest Investigative Site 037 — Mount Kisco, New York, United States
• Forest Investigative Site 067 — New York, New York, United States
• Forest Investigative Site 049 — New York, New York, United States
• Forest Investigative Site 047 — Canton, Ohio, United States
• Forest Investigative Site 077 — Garden Grove, California, United States

Full record on ClinicalTrials.gov

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