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
1 other identifier
interventional
231
1 country
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Jun 2009
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 2, 2009
CompletedStudy Start
First participant enrolled
June 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2010
CompletedResults Posted
Study results publicly available
March 5, 2019
CompletedMarch 5, 2019
February 1, 2019
1.4 years
February 26, 2009
July 30, 2018
February 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Montgomery-Asberg Depression Rating Scale (MADRS)
The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.
Baseline (Week 8) to Week 16
Secondary Outcomes (1)
Clinical Global Impression - Improvement (CGI-I)
Week 16
Study Arms (3)
Placebo
PLACEBO COMPARATORDrug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo
Cariprazine 0.1 - 0.3 mg
EXPERIMENTALDrug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose
Cariprazine 1.0 - 2.0 mg
EXPERIMENTALDrug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
Interventions
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 (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 (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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Forest Laboratorieslead
- Gedeon Richter Ltd.collaborator
Study Sites (41)
Forest Investigative Site 040
Phoenix, Arizona, 85050, United States
Forest Investigative Site 038
Scottsdale, Arizona, 85254, United States
Forest Investigative Site
Arcadia, California, 91007, United States
Forest Investigative Site
Encino, California, 91316, United States
Forest Investigative Site
Garden Grove, California, 92845, United States
Forest Investigative Site
Irvine, California, 92618, United States
Forest Investigative Site 013
Los Alamitos, California, 90720, United States
Forest Investigative Site 041
National City, California, 91950, United States
Forest Investigative Site
Oceanside, California, 92056, United States
Forest Investigative Site 025
Denver, Colorado, 80239, United States
Forest Investigative Site
Norwich, Connecticut, 06360, United States
Forest Investigative Site
Washington D.C., District of Columbia, 20016, United States
Forest Investigative Site 007
Jacksonville, Florida, 32216, United States
Forest Investigative Site 012
West Palm Beach, Florida, 33407, United States
Forest Investigative Site 033
Atlanta, Georgia, 30306, United States
Forest Investigative Site
Roswell, Georgia, 30076, United States
Forest Investigative Site
Overland Park, Kansas, 66211, United States
Forest Investigative Site 042
Fall River, Massachusetts, 02721, United States
Forest Investigative Site 034
Pittsfield, Massachusetts, 01267, United States
Forest Investigative Site
Omaha, Nebraska, 68131, United States
Forest Investigative Site
Cherry Hill, New Jersey, 08002, United States
Forest Investigative Site 043
Brooklyn, New York, 11235, United States
Forest Investigative Site 020
Mount Kisco, New York, 10549, United States
Forest Investigative Site 039
New York, New York, 10003, United States
Forest Investigative Site 029
New York, New York, 10021, United States
Forest Investigative Site 001
The Bronx, New York, 10467, United States
Forest Investigative Site 032
Raleigh, North Carolina, 27607, United States
Forest Investigative Site
Canton, Ohio, 44718, United States
Forest Investigative Site
Dayton, Ohio, 45417, United States
Forest Investigative Site 015
Portland, Oregon, 97210, United States
Forest Investigative Site 006
Media, Pennsylvania, 19063, United States
Forest Investigative Site
Philadelphia, Pennsylvania, 19104, United States
Forest Investigative Site
Philadelphia, Pennsylvania, 19107, United States
Forest Investigative Site 023
Memphis, Tennessee, 38119, United States
Forest Investigative Site 031
Memphis, Tennessee, 38119, United States
Forest Investigative Site
Nashville, Tennessee, 37212, United States
Forest Investigative Site
San Antonio, Texas, 78229, United States
Forest Investigative Site
Woodstock, Vermont, 05091, United States
Forest Investigative Site
Richmond, Virginia, 23230, United States
Forest Investigative Site
Bellevue, Washington, 98007, United States
Forest Investigative Site
Seattle, Washington, 98104, United States
Related Publications (1)
Fava M, Durgam S, Earley W, Lu K, Hayes R, Laszlovszky I, Nemeth G. Efficacy of adjunctive low-dose cariprazine in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2018 Nov;33(6):312-321. doi: 10.1097/YIC.0000000000000235.
PMID: 30045066DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Robert Hayes, PhD
Forest Laboratories
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2009
First Posted
March 2, 2009
Study Start
June 30, 2009
Primary Completion
December 6, 2010
Study Completion
December 6, 2010
Last Updated
March 5, 2019
Results First Posted
March 5, 2019
Record last verified: 2019-02