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Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00854100
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : February 8, 2012
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

February 26, 2009
March 2, 2009
February 8, 2012
June 2009
December 2010   (Final data collection date for primary outcome measure)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 16 ]
Same as current
Complete list of historical versions of study NCT00854100 on ClinicalTrials.gov Archive Site
Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Week 16 ]
Hamilton Depression Rating Scale - 24-Item (HAMD-24) [ Time Frame: Week 16 ]
Not Provided
Not Provided
 
Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Antidepressant + placebo
    Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
  • Drug: Antidepressant + cariprazine (0.1-0.3 mg/day)
    Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
  • Drug: Antidepressant + cariprazine (1-2 mg/d)
    Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
  • Placebo Comparator: 1
    Drug: Antidepressant + Placebo
    Intervention: Drug: Antidepressant + placebo
  • Experimental: 2
    Drug: Antidepressant + cariprazine low dose
    Intervention: Drug: Antidepressant + cariprazine (0.1-0.3 mg/day)
  • Experimental: 3
    Drug: Antidepressant + cariprazine high dose
    Intervention: Drug: Antidepressant + cariprazine (1-2 mg/d)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
232
500
Not Provided
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women, 18-65 years old
  • Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features.
  • Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode.

Exclusion Criteria:

  • DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
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
United States
 
 
NCT00854100
RGH-MD-71
No
Not Provided
Not Provided
Forest Laboratories
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Robert Hayes, PhD Forest Laboratories
Forest Laboratories
February 2012

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