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Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy in Major Depressive Disorder

NCT01469377•Forest Laboratories

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).

Exclusion Criteria

•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:
•1. Depressive episode with psychotic or catatonic features.
•2. Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
•3. Schizophrenia, schizoaffective, or other psychotic disorder.
•4. Obsessive-compulsive disorder.
•5. Bulimia or anorexia nervosa.
•6. Dementia, amnesic, or other cognitive disorder.
•7. Mental retardation.
+1 more criteria

Locations (72)

Forest Investigative Site 077

Garden Grove, California, United States

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

Key Dates

Start Date

December 15, 2011

Primary Completion Date

December 12, 2013

Completion Date

December 12, 2013

Last Updated

May 1, 2018

Enrollment

819

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Placebo

DRUG

Cariprazine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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