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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01715805
First Posted: October 29, 2012
Last Update Posted: June 8, 2016
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.
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ]
    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 ]
    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 2016
Estimated Primary Completion Date: June 2016 (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

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT01715805


  Show 85 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Yao Wang, MD Forest Laboratories Inc, an affiliate of Allergan plc
  More Information

Additional Information:
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01715805     History of Changes
Other Study ID Numbers: RGH-MD-72
First Submitted: October 25, 2012
First Posted: October 29, 2012
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by Forest Laboratories:
MDD
Major Depressive Disorder

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