Clinical trial NCT00097266: Study of Aripiprazole in Patients With Acute Bipolar 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: 2004-11-22
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.


Eligibility criteria: Inclusion Criteria:

* Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.

Primary outcomes:
measure: Change in a mania rating scale at endpoint
Secondary outcomes:
measure: Response rate and Clinical Global Impression scale at endpoint
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Local Institution
state: California
city: Cerritos
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: Pico Rivera
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: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Maitland
country: United States
facility: Local Institution
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Shreveport
country: United States
facility: Local Institution
state: Louisiana
city: Albuquerque
country: United States
facility: Local Institution
state: New Mexico
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Desoto
country: United States
facility: Local Institution
state: Texas
city: Burgas
country: Bulgaria
facility: Local Institution
city: Novi Iskar
country: Bulgaria
facility: Local Institution
city: Pleven
country: Bulgaria
facility: Local Institution
city: Sofia
country: Bulgaria
facility: Local Institution
city: Varna
country: Bulgaria
facility: Local Institution
city: Osijek
country: Croatia
facility: Local Institution
city: Rijeka
country: Croatia
facility: Local Institution
city: Split
country: Croatia
facility: Local Institution
city: Zagreb
country: Croatia
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Col. Obispado
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Fracc. Industrias
country: Mexico
facility: Local Institution
state: San Luis Potosi
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Nuevo Leon
country: Mexico
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lipetsk
country: Russian Federation
facility: Local Institution
state: Lipetsk Region
city: Arkhangelsk
country: Russian Federation
facility: Local Institution
city: Kazan
country: Russian Federation
facility: Local Institution
city: Leningrad Region
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Nizhniy Novgorod
country: Russian Federation
facility: Local Institution
city: Samara
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Volgograd
country: Russian Federation
facility: Local Institution
city: Florida
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Berea
country: South Africa
facility: Local Institution
state: Kwa Zuluu Natal
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Young AH, Oren DA, Lowy A, McQuade RD, Marcus RN, Carson WH, Spiller NH, Torbeyns AF, Sanchez R. Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study. Br J Psychiatry. 2009 Jan;194(1):40-8. doi: 10.1192/bjp.bp.108.049965.