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An Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

This study is currently recruiting participants.
Verified March 2013 by Forest Laboratories
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01715805
First received: October 25, 2012
Last updated: March 24, 2013
Last verified: March 2013
History of Changes
  Purpose

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD


Condition Intervention Phase
Major Depressive Disorder
 Drug: Cariprazine
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder (MDD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated scale. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.


Secondary Outcome Measures:
  • Sheehan Disability Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe).


Estimated Enrollment: 1100
Study Start Date: November 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cariprazine
Cariprazine, 1.5 milligrams to 4.5 milligrams per day, oral administration.
 Drug: Cariprazine
Patients who meet eligibility will have 1-2 week screening period followed by blind placebo, followed by 8 week double blind treatment period on cariprazine with Antidepressant Therapy (ADT) or placebo with ADT for inadequate responders and ADT with single blind placebo for responders, followed by a 1-week safety follow-up period
Placebo Comparator: Placebo
Dose-matched placebo, onec per day, oral administration
 Drug: Placebo
Patients who meet eligibility will have 1-2 week screening period followed by blind placebo, followed by 8 week double blind treatment period on placebo with Antidepressant Therapy (ADT) for inadequate responders and ADT with single blind placebo for responders, followed by a 1-week safety follow-up period

  Eligibility

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

Inclusion Criteria:

  • Patients who have provided consent prior to any specific procedure
  • Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
  • Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2

Exclusion Criteria:

  • Patients who do not meet DSM-IV-TR criteria for MDD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715805

Contacts
Contact: Sandra Beaird, PharmD 1-800-678-1605 ext 66297 FRXClinTrials@frx.com

  Show 61 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Suneeta Ahuja, PhD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01715805     History of Changes
Other Study ID Numbers: RGH-MD-72
Study First Received: October 25, 2012
Last Updated: March 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
MDD
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
 Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013