Clinical trial NCT01715805: Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
Official title: A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: MDD
Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2012-10-29
Enrollment: 1022
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: 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


Eligibility criteria: 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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period
timeFrame: Baseline (Week 8)
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period
timeFrame: Baseline (Week 8) to Week 16
Secondary outcomes:
measure: Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period
timeFrame: Baseline (Week 8) to Week 16
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Forest Investigative Site 032
state: Arizona
city: Little Rock
country: United States
facility: Forest Investigative Site 018
state: Arkansas
city: Little Rock
country: United States
facility: Forest Investigative Site 029
state: Arkansas
city: Cerritos
country: United States
facility: Forest Investigative Site 084
state: California
city: Culver City
country: United States
facility: Forest Investigative Site 085
state: California
city: Garden Grove
country: United States
facility: Forest Investigative Site 082
state: California
city: Newport Beach
country: United States
facility: Forest Investigative Site 022
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 004
state: California
city: Rancho Mirage
country: United States
facility: Forest Investigative Site 090
state: California
city: Redlands
country: United States
facility: Forest Investigative Site 078
state: California
city: Redlands
country: United States
facility: Forest Investigative Site 080
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 007
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 054
state: California
city: Temecula
country: United States
facility: Forest Investigative Site 031
state: California
city: Denver
country: United States
facility: Forest Investigative Site 048
state: Colorado
city: Coral Springs
country: United States
facility: Forest Investigative Site 037
state: Florida
city: Fort Myers
country: United States
facility: Forest Investigative Site 053
state: Florida
city: Hallandale Beach
country: United States
facility: Forest Investigative Site 023
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site 071
state: Florida
city: Leesburg
country: United States
facility: Forest Investigative Site 006
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 026
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 075
state: Florida
city: North Miami
country: United States
facility: Forest Investigative Site 027
state: Florida
city: North Miami
country: United States
facility: Forest Investigative Site 074
state: Florida
city: Oakland Park
country: United States
facility: Forest Investigative Site 036
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 051
state: Florida
city: South Miami
country: United States
facility: Forest Investigative Site 044
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 008
state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 019
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 060
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site 024
state: Georgia
city: Marietta
country: United States
facility: Forest Investigative Site 017
state: Georgia
city: Smyrna
country: United States
facility: Forest Investigative Site 047
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site 070
state: Illinois
city: Hoffman Estates
country: United States
facility: Forest Investigative Site 013
state: Illinois
city: Libertyville
country: United States
facility: Forest Investigative Site 063
state: Illinois
city: Maywood
country: United States
facility: Forest Investigative Site 062
state: Illinois
city: Naperville
country: United States
facility: Forest Investigative Site 072
state: Illinois
city: Oak Brook
country: United States
facility: Forest Investigative Site 010
state: Illinois
city: Skokie
country: United States
facility: Forest Investigative Site 068
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigative Site 061
state: Indiana
city: Lafayette
country: United States
facility: Forest Investigative Site 042
state: Indiana
city: Overland Park
country: United States
facility: Forest Investigative Site 065
state: Kansas
city: New Orleans
country: United States
facility: Forest Investigative Site 073
state: Louisiana
city: Gaithersburg
country: United States
facility: Forest Investigative Site 049
state: Maryland
city: Rockville
country: United States
facility: Forest Investigative Site 077
state: Maryland
city: Rockville
country: United States
facility: Forest Investigative Site 012
state: Maryland
city: Boston
country: United States
facility: Forest Investigative Site 046
state: Massachusetts
city: Natick
country: United States
facility: Forest Investigative Site 045
state: Massachusetts
city: Saint Charles
country: United States
facility: Forest Investigative Site 086
state: Missouri
city: Toms River
country: United States
facility: Forest Investigative Site 014
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 058
state: New Mexico
city: Bronx
country: United States
facility: Forest Investigative Site 076
state: New York
city: Brooklyn
country: United States
facility: Forest Investigative Site 028
state: New York
city: New York
country: United States
facility: Forest Investigative Site 016
state: New York
city: New York
country: United States
facility: Forest Investigative Site 083
state: New York
city: Staten Island
country: United States
facility: Forest Investigative Site 025
state: New York
city: Durham
country: United States
facility: Forest Investigative Site 050
state: North Carolina
city: Bismarck
country: United States
facility: Forest Investigative Site 067
state: North Dakota
city: Canton
country: United States
facility: Forest Investigative Site 088
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 089
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 011
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 015
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 055
state: Ohio
city: Mason
country: United States
facility: Forest Investigative Site 066
state: Ohio
city: Middleburg Heights
country: United States
facility: Forest Investigative Site 064
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 035
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 038
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 039
state: Oklahoma
city: Portland
country: United States
facility: Forest Investigative Site 003
state: Oregon
city: Allentown
country: United States
facility: Forest Investigative Site 052
state: Pennsylvania
city: Lincoln
country: United States
facility: Forest Investigative Site 059
state: Rhode Island
city: Charleston
country: United States
facility: Forest Investigative Site 001
state: South Carolina
city: Austin
country: United States
facility: Forest Investigative Site 079
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 005
state: Texas
city: The Woodlands
country: United States
facility: Forest Investigative Site 087
state: Texas
city: Wichita Falls
country: United States
facility: Forest Investigative Site 069
state: Texas
city: Orem
country: United States
facility: Forest Investigative Site 030
state: Utah
city: Charlottesville
country: United States
facility: Forest Investigative Site 041
state: Virginia
city: Bellevue
country: United States
facility: Forest Investigative Site 081
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site 043
state: Washington
city: Milwaukee
country: United States
facility: Forest Investigative Site 056
state: Wisconsin
city: Waukesha
country: United States
facility: Forest Investigative Site 057
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Forest Investigative Site 033
city: San Juan
country: Puerto Rico
facility: Forest Investigative Site 034
Study officials:
affiliation: Allergan
name: Willie Earley, MD
role: STUDY_DIRECTOR
References:
citation: Earley WR, Guo H, Nemeth G, Harsanyi J, Thase ME. Cariprazine Augmentation to Antidepressant Therapy in Major Depressive Disorder: Results of a Randomized, Double-Blind, Placebo-Controlled Trial. Psychopharmacol Bull. 2018 Jun 20;48(4):62-80.