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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)

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ClinicalTrials.gov Identifier: NCT01715805
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

October 25, 2012
October 29, 2012
March 12, 2018
November 15, 2012
June 24, 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01715805 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
An Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder (MDD)
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • 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
  • 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
  • Experimental: Cariprazine
    Cariprazine, 1.5 milligrams to 4.5 milligrams per day, oral administration.
    Intervention: Drug: Cariprazine
  • Placebo Comparator: Placebo
    Dose-matched placebo, onec per day, oral administration
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
530
1100
June 24, 2016
June 24, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT01715805
RGH-MD-72
No
Not Provided
Not Provided
Forest Laboratories
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Willie Earley, MD Allergan
Forest Laboratories
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP