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NCT03605784 Clinical Trial

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

Major Depressive Disorder Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03605784
Other study ID # RGH-MD-71
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 30, 2009
Est. completion date December 6, 2010

Study information
Verified date July 2018
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 232
Est. completion date December 6, 2010
Est. primary completion date December 6, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.
• 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.

Locations
Country Name City State
United States Forest Investigative Site Arcadia California
United States Forest Investigative Site 033 Atlanta Georgia
United States Forest Investigative Site Bellevue Washington
United States Forest Investigative Site 001 Bronx New York
United States Forest Investigative Site 043 Brooklyn New York
United States Forest Investigative Site Canton Ohio
United States Forest Investigative Site Cherry Hill New Jersey
United States Forest Investigative Site Dayton Ohio
United States Forest Investigative Site 025 Denver Colorado
United States Forest Investigative Site Encino California
United States Forest Investigative Site 042 Fall River Massachusetts
United States Forest Investigative Site Garden Grove California
United States Forest Investigative Site Irvine California
United States Forest Investigative Site 007 Jacksonville Florida
United States Forest Investigative Site 013 Los Alamitos California
United States Forest Investigative Site 006 Media Pennsylvania
United States Forest Investigative Site 023 Memphis Tennessee
United States Forest Investigative Site 031 Memphis Tennessee
United States Forest Investigative Site 020 Mount Kisco New York
United States Forest Investigative Site Nashville Tennessee
United States Forest Investigative Site 041 National City California
United States Forest Investigative Site 029 New York New York
United States Forest Investigative Site 039 New York New York
United States Forest Investigative Site Norwich Connecticut
United States Forest Investigative Site Oceanside California
United States Forest Investigative Site Omaha Nebraska
United States Forest Investigative Site Overland Park Kansas
United States Forest Investigative Site Philadelphia Pennsylvania
United States Forest Investigative Site Philadelphia Pennsylvania
United States Forest Investigative Site 040 Phoenix Arizona
United States Forest Investigative Site 034 Pittsfield Massachusetts
United States Forest Investigative Site 015 Portland Oregon
United States Forest Investigative Site 032 Raleigh North Carolina
United States Forest Investigative Site Richmond Virginia
United States Forest Investigative Site Roswell Georgia
United States Forest Investigative Site San Antonio Texas
United States Forest Investigative Site 038 Scottsdale Arizona
United States Forest Investigative Site Seattle Washington
United States Forest Investigative Site Washington District of Columbia
United States Forest Investigative Site 012 West Palm Beach Florida
United States Forest Investigative Site Woodstock Vermont

Sponsors (2)
Lead Sponsor Collaborator
Allergan Gedeon Richter Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Montgomery-Asberg Depression Rating Scale (MADRS) MADRS is assessed on a scale from 0 to 60 where 0 indicated the absence of symptoms and a score of 60 indicated symptoms of maximum severity. Week 16
Secondary Clinical Global Impression - Improvement (CGI-I) Week 16
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