Clinical trial NCT00095511: Aripiprazole in Patients With Acute Mania
Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Bipolar Mania
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2004-11-08
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Acute Bipolar I Mania

Exclusion Criteria:

* Patients with a DSM-IV diagnosis other than Bipolar I Mania

Primary outcomes:
measure: Change from baseline to endpoint in a mania rating scale
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: Scottsdale
country: United States
facility: Local Institution
state: Arizona
city: Cerritos
country: United States
facility: Local Institution
state: California
city: Garden Grove
country: United States
facility: Local Institution
state: California
city: La Palma
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: Middletown
country: United States
facility: Local Institution
state: Connecticut
city: New Haven
country: United States
facility: Local Institution
state: Connecticut
city: Bradenton
country: United States
facility: Local Institution
state: Florida
city: Kissimmee
country: United States
facility: Local Institution
state: Florida
city: Maitland
country: United States
facility: Local Institution
state: Florida
city: Augusta
country: United States
facility: Local Institution
state: Georgia
city: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Hoffman Estates
country: United States
facility: Local Institution
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: New Orleans
country: United States
facility: Local Institution
state: Louisiana
city: Shreveport
country: United States
facility: Local Institition
state: Louisiana
city: Saint Charles
country: United States
facility: Local Institution
state: Missouri
city: Clementon
country: United States
facility: Local Institution
state: New Jersey
city: Cedarhurst
country: United States
facility: Local Institution
state: New York
city: Elmsford
country: United States
facility: Local Institution
state: New York
city: Holliswood
country: United States
facility: Local Institution
state: New York
city: Morganton
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: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Lyndhurst
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Norristown
country: United States
facility: Local Institution
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Bellaire
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Arlington
country: United States
facility: Local Institution
state: Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Keck PE, Orsulak PJ, Cutler AJ, Sanchez R, Torbeyns A, Marcus RN, McQuade RD, Carson WH; CN138-135 Study Group. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placebo- and lithium-controlled study. J Affect Disord. 2009 Jan;112(1-3):36-49. doi: 10.1016/j.jad.2008.05.014. Epub 2008 Oct 2.
citation: McIntyre RS, McElroy SL, Eudicone JM, Forbes RA, Carlson BX, Baker RA. A 52-week, double-blind evaluation of the metabolic effects of aripiprazole and lithium in bipolar I disorder. Prim Care Companion CNS Disord. 2011;13(6):PCC.11m01182. doi: 10.4088/PCC.11m01182.