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

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01469377
First received: November 8, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: cariprazine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sheehan Disability Scale (SDS) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Enrollment: 819
Study Start Date: December 2011
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469377

  Show 72 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Alan Lipschitz, MD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01469377     History of Changes
Other Study ID Numbers: RGH-MD-75
Study First Received: November 8, 2011
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration
Slovakia: State Institute for Drug Control
Finland: Ministry of Social Affairs and Health
Ukraine: Ministry of Health
Sweden: Medical Products Agency
Estonia: The State Agency of Medicine

Keywords provided by Forest Laboratories:
Major Depressive Disorder
Depression

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

ClinicalTrials.gov processed this record on September 30, 2014