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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01469377
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : February 28, 2014
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to Antidepressant Therapy (ADT) in patients with Major Depressive Disorder (MDD) who have an inadequate response to antidepressant alone. This clinical study will be comparing cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT in the current episode. The study will consist of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: cariprazine Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 819 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study Of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder
Study Start Date : December 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: cariprazine 2-4.5 mg Drug: cariprazine
cariprazine (2-4.5 mg/day) given orally, in capsule form, once daily for 8 weeks
Experimental: cariprazine 1-2 mg/day Drug: cariprazine
cariprazine (1-2 mg/day) given orally, in capsule form, once daily for 8 weeks
Placebo Comparator: Placebo Drug: placebo
Matched placebo given orally, in capsule form, once daily for 8 weeks

Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. Sheehan Disability Scale (SDS) [ Time Frame: 8 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 MDD
  • Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration
  • Ongoing inadequate response to protocol allowed 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
  • Patients considered a suicide risk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01469377

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Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Alan Lipschitz, MD Forest Laboratories

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Forest Laboratories Identifier: NCT01469377     History of Changes
Other Study ID Numbers: RGH-MD-75
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014

Keywords provided by Forest Laboratories:
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms