Clinical trial NCT01838876: Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
Official title: A Phase 3, Long-term, Open-label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
MDD
Depression
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2013-04-24
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).


Eligibility criteria: Inclusion Criteria:

* Patients who have provided consent prior to any study specific procedures
* Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD
* New patients must have ongoing inadequate response to protocol allowed ADTs as reported in Antidepressant Treatment Response Questionnaire (ATRQ)
* For rollover patients from RGH-MD-72 \[NCT01715805\], completion of Study RGH-MD-72 (either double-blind or single-blind treatment periods) with continued ADT treatment.

Exclusion Criteria:

* Patients who do not meet the DSM-IV-TR criteria for MDD.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
timeFrame: First dose of study drug to last dose of study drug in the 26-week Treatment Period and within 30 days of last dose of study drug for participants who did not participate in the 2-week Safety Follow-up Period (Up to 30 weeks)
measure: Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period
timeFrame: 2 weeks following the 26-week Treatment Period
measure: Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
timeFrame: Baseline (Week 0) to up to 26 weeks in the Treatment Period
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
timeFrame: Baseline (Week 0) to up to 26 weeks in the Treatment Period plus a 2-week Safety Follow-up Period (Up to 28 weeks)
measure: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
timeFrame: Baseline (Week 0) to up to 26 weeks
measure: Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs
timeFrame: First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)
measure: Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period
timeFrame: Baseline (Lead-in study Baseline for roll-over participants and prior to first dose in this study for new participants) to Week 26 in this study
measure: Number of Participants With Treatment-Emergent Ocular Events
timeFrame: First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)
measure: Change From Baseline in the Arizona Sexual Experiences Scale (ASEX) Score
timeFrame: Baseline (Lead-in study Baseline for roll-over participants and prior to first dose of this study for new participants) to End of Treatment (Up to Week 26) in this study
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Forest Investigative Site 032
state: Arizona
city: Tucson
country: United States
facility: Forest Investigative Site 109
state: Arizona
city: Fayetteville
country: United States
facility: Forest Investigative Site 105
state: Arkansas
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: Garden Grove
country: United States
facility: Forest Investigative Site 082
state: California
city: Long Beach
country: United States
facility: Forest Investigative Site 107
state: California
city: National City
country: United States
facility: Forest Investigative Site 104
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 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 113
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 054
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 007
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: Norwich
country: United States
facility: Forest Investigative Site 114
state: Connecticut
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: Maitland
country: United States
facility: Forest Investigative Site 112
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 110
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 103
state: Missouri
city: Berlin
country: United States
facility: Forest Investigative Site 106
state: New Jersey
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: 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: 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 038
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 035
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: Norristown
country: United States
facility: Forest Investigative Site 102
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 108
state: Texas
city: Wichita Falls
country: United States
facility: Forest Investigative Site 069
state: Texas
city: Murray
country: United States
facility: Forest Investigative Site 111
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: Bothell
country: United States
facility: Forest Investigative Site 100
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site 043
state: Washington
city: Middleton
country: United States
facility: Forest Investigative Site 101
state: Wisconsin
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: