Clinical trial NCT00854100: Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
Official title: A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Adjunctive
Depression
Major Depressive Disorder (MDD)
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2009-03-02
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline (Week 8) to Week 16
Secondary outcomes:
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Forest Investigative Site 040
state: Arizona
city: Scottsdale
country: United States
facility: Forest Investigative Site 038
state: Arizona
city: Arcadia
country: United States
facility: Forest Investigative Site
state: California
city: Encino
country: United States
facility: Forest Investigative Site
state: California
city: Garden Grove
country: United States
facility: Forest Investigative Site
state: California
city: Irvine
country: United States
facility: Forest Investigative Site
state: California
city: Los Alamitos
country: United States
facility: Forest Investigative Site 013
state: California
city: National City
country: United States
facility: Forest Investigative Site 041
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site
state: California
city: Denver
country: United States
facility: Forest Investigative Site 025
state: Colorado
city: Norwich
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Washington
country: United States
facility: Forest Investigative Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Forest Investigative Site 007
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 012
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 033
state: Georgia
city: Roswell
country: United States
facility: Forest Investigative Site
state: Georgia
city: Overland Park
country: United States
facility: Forest Investigative Site
state: Kansas
city: Fall River
country: United States
facility: Forest Investigative Site 042
state: Massachusetts
city: Pittsfield
country: United States
facility: Forest Investigative Site 034
state: Massachusetts
city: Omaha
country: United States
facility: Forest Investigative Site
state: Nebraska
city: Cherry Hill
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Bronx
country: United States
facility: Forest Investigative Site 001
state: New York
city: Brooklyn
country: United States
facility: Forest Investigative Site 043
state: New York
city: Mount Kisco
country: United States
facility: Forest Investigative Site 020
state: New York
city: New York
country: United States
facility: Forest Investigative Site 039
state: New York
city: New York
country: United States
facility: Forest Investigative Site 029
state: New York
city: Raleigh
country: United States
facility: Forest Investigative Site 032
state: North Carolina
city: Canton
country: United States
facility: Forest Investigative Site
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site
state: Ohio
city: Portland
country: United States
facility: Forest Investigative Site 015
state: Oregon
city: Media
country: United States
facility: Forest Investigative Site 006
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Memphis
country: United States
facility: Forest Investigative Site 023
state: Tennessee
city: Memphis
country: United States
facility: Forest Investigative Site 031
state: Tennessee
city: Nashville
country: United States
facility: Forest Investigative Site
state: Tennessee
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: Woodstock
country: United States
facility: Forest Investigative Site
state: Vermont
city: Richmond
country: United States
facility: Forest Investigative Site
state: Virginia
city: Bellevue
country: United States
facility: Forest Investigative Site
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site
state: Washington
Study officials:
affiliation: Forest Laboratories
name: Robert Hayes, PhD
role: STUDY_DIRECTOR
References:
citation: 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.