Clinical trial NCT00094432: A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive 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. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Keywords: depressed
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2004-10-19
Enrollment: 650
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 several doses of aripiprazole in patients with bipolar depression.


Eligibility criteria: Inclusion Criteria:

* Men and women, ages 18-65
* Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.

Primary outcomes:
measure: Mean change from baseline to endpoint on the MADRS total score.
Secondary outcomes:
measure: Clinical Global Impression - Bipolar Version
measure: Severity of illness score depression
measure: Mean change from baseline to endpoint
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Local Institution
state: Arizona
city: La Mesa
country: United States
facility: Local Institution
state: California
city: La Palma
country: United States
facility: Local Institution
state: California
city: Long Beach
country: United States
facility: Local Institution
state: California
city: Redlands
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: Sherman Oaks
country: United States
facility: Local Institution
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Coral Springs
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: St. Petersburg
country: United States
facility: Local Institution
state: Florida
city: Marietta
country: United States
facility: Local Institution
state: Georgia
city: Edwardsville
country: United States
facility: Local Institution
state: Illinois
city: Oak Brook
country: United States
facility: Local Institution
state: Illinois
city: Springfield
country: United States
facility: Local Institution
state: Illinois
city: Lafayette
country: United States
facility: Local Institution
state: Indiana
city: Newton
country: United States
facility: Local Institution
state: Kansas
city: New Orleans
country: United States
facility: Local Institution
state: Louisiana
city: Shreveport
country: United States
facility: Local Institution
state: Louisiana
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: Clementon
country: United States
facility: Local Institution
state: New Jersey
city: Alburquerque
country: United States
facility: Local Institution
state: New Mexico
city: Brooklyn
country: United States
facility: Local Institution
state: New York
city: Elmsford
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Raleigh
country: United States
facility: Local Institution
state: North Carolina
city: Dayton
country: United States
facility: Local Institution
state: Ohio
city: Media
country: United States
facility: Local Institution
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Columbia
country: United States
facility: Local Institution
state: South Carolina
city: Desoto
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Wichita Falls
country: United States
facility: Local Institution
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution
state: Utah
city: Charlottesville
country: United States
facility: Local Institution
state: Virginia
city: Midlothian
country: United States
facility: Local Institution
state: Virginia
city: Bellevue
country: United States
facility: Local Institution
state: Washington
city: Charleston
country: United States
facility: Local Institution
state: West Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: