Clinical trial NCT00095745: A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder
Official title: A Multicenter, Long-Term, Open-label, Study to Assess the Safety and Tolerability of Aripiprazole as an Adjunctive Therapy in the Treatment of Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2004-11-09
Enrollment: 1002
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.


Eligibility criteria: Inclusion Criteria:

* Men and women, 18 years or older
* Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
* Treatment history of an inadequate response to at least one and no more than four antidepressants

Primary outcomes:
measure: Safety assessments
timeFrame: throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Local Institution
state: Arizona
city: Peoria
country: United States
facility: Local Institution
state: Arizona
city: Beverly Hills
country: United States
facility: Local Institution
state: California
city: Burbank
country: United States
facility: Local Institution
state: California
city: Encino
country: United States
facility: Local Institution
state: California
city: Garden Grove
country: United States
facility: Local Institution
state: California
city: National City
country: United States
facility: Local Institution
state: California
city: Orange
country: United States
facility: Local Institution
state: California
city: Pasadena
country: United States
facility: Local Institution
state: California
city: Riverside
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: Denver
country: United States
facility: Local Institution
state: Colorado
city: Farmington
country: United States
facility: Local Institution
state: Connecticut
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Gainesville
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: Atlanta
country: United States
facility: Local Institution
state: Georgia
city: Smyrna
country: United States
facility: Local Institution
state: Georgia
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Edwardsville
country: United States
facility: Local Institution
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Local Institution
state: Illinois
city: Terre Haute
country: United States
facility: Local Institution
state: Indiana
city: Overland Park
country: United States
facility: Local Institution
state: Kansas
city: Wichita
country: United States
facility: Local Institution
state: Kansas
city: Lexington
country: United States
facility: Local Institution
state: Kentucky
city: Rockville
country: United States
facility: Local Institution
state: Maryland
city: Springfield
country: United States
facility: Local Institution
state: Massachusetts
city: Farmington Hills
country: United States
facility: Local Institution
state: Michigan
city: Okemos
country: United States
facility: Local Institution
state: Michigan
city: Albuquerque
country: United States
facility: Local Institution
state: New Mexico
city: Brooklyn
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Staten Island
country: United States
facility: Local Institution
state: New York
city: Chapel Hill
country: United States
facility: Local Institution
state: North Carolina
city: Raleigh
country: United States
facility: Local Institution
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Toledo
country: United States
facility: Local Institution
state: Ohio
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: East Providence
country: United States
facility: Local Institution
state: Rhode Island
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Memphis
country: United States
facility: Local Institution
state: Tennessee
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution
state: Utah
city: Woodstock
country: United States
facility: Local Institution
state: Vermont
city: Arlington
country: United States
facility: Local Institution
state: Virginia
city: Charlottesville
country: United States
facility: Local Institution
state: Virginia
city: Herndon
country: United States
facility: Local Institution
state: Virginia
city: Richmond
country: United States
facility: Local Institution
state: Virginia
city: Bellevue
country: United States
facility: Local Institution
state: Washington
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: Morgantown
country: United States
facility: Local Institution
state: West Virginia
city: Brown Deer
country: United States
facility: Local Institution
state: Wisconsin
city: Middleton
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Clayton AH, Baker RA, Sheehan JJ, Cain ZJ, Forbes RA, Marler SV, Marcus R, Berman RM, Thase ME. Comparison of adjunctive use of aripiprazole with bupropion or selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors: analysis of patients beginning adjunctive treatment in a 52-week, open-label study. BMC Res Notes. 2014 Jul 18;7:459. doi: 10.1186/1756-0500-7-459.