Clinical trial NCT00080314: Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Bipolar 1 Disorder, depressed
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2004-03-30
Enrollment: 400
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 purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.


Eligibility criteria: * ages 18-65
* Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.

Primary outcomes:
measure: Change on a depression rating scale at endpoint
Secondary outcomes:
measure: Response rate and Clinical Global Impression scale at endpoint
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Local Institution
state: Alabama
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: San Diego
country: United States
facility: Local Institution
state: California
city: Sherman Oaks
country: United States
facility: Local Institution
state: California
city: Norwich
country: United States
facility: Local Institution
state: Connecticut
city: West Haven
country: United States
facility: Local Institution
state: Connecticut
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Maitland
country: United States
facility: Local Institution
state: Florida
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: Honolulu
country: United States
facility: Local Insstitution
state: Hawaii
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Lake Charles
country: United States
facility: Local Institution
state: Louisiana
city: Rockville
country: United States
facility: Local Institution
state: Maryland
city: Durham
country: United States
facility: Local Institution
state: North Carolina
city: Raleigh
country: United States
facility: Local Institution
state: North Carolina
city: Beachwood
country: United States
facility: Local Institution
state: Ohio
city: Dayton
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Media
country: United States
facility: Local Institution
state: Pennsylvania
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: Lake Jackson
country: United States
facility: Local Institution
state: Texas
city: Wichita Falls
country: United States
facility: Local Institution
state: Texas
city: Arlington
country: United States
facility: Local Institution
state: Virginia
city: Bellevue
country: United States
facility: Local Institution
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: