Study of Aripiprazole in Patients With Acute Bipolar Mania

Bipolar Disorder Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097266
• Other study ID #: CN138-162
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2004
• Last updated: November 7, 2013
• Start date: December 2004
• Est. completion date: January 2007

Study information

• Verified date: July 2010
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Placebo
Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).
• Aripiprazole
Tablets, oral, 15-30 mg, once daily, 12 weeks.
• Haloperidol
Capsule, oral, 5-15 mg, once daily, 12 weeks.

Locations

Country	Name	City	State
Bulgaria	Local Institution	Burgas
Bulgaria	Local Institution	Novi Iskar
Bulgaria	Local Institution	Pleven
Bulgaria	Local Institution	Sofia
Bulgaria	Local Institution	Varna
Croatia	Local Institution	Osijek
Croatia	Local Institution	Rijeka
Croatia	Local Institution	Split
Croatia	Local Institution	Zagreb
Mexico	Local Institution	Col. Obispado	Nuevo Leon
Mexico	Local Institution	Fracc. Industrias	San Luis Potosi
Mexico	Local Institution	Merida	Yucatan
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Nuevo Leon
Mexico	Local Institution	Zapopan	Jalisco
Peru	Local Institution	Lima
Russian Federation	Local Institution	Arkhangelsk
Russian Federation	Local Institution	Kazan
Russian Federation	Local Institution	Leningrad Region
Russian Federation	Local Institution	Lipetsk	Lipetsk Region
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Nizhniy Novgorod
Russian Federation	Local Institution	Samara
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	Volgograd
South Africa	Local Institution	Berea	Kwa Zuluu Natal
South Africa	Local Institution	Durban	Kwa Zulu Natal
South Africa	Local Institution	Florida	Gauteng
South Africa	Local Institution	Pretoria	Gauteng
United States	Local Institution	Albuquerque	New Mexico
United States	Local Institution	Anaheim	California
United States	Local Institution	Cerritos	California
United States	Local Institution	Cleveland	Ohio
United States	Local Institution	Desoto	Texas
United States	Local Institution	Garden Grove	California
United States	Local Institution	Maitland	Florida
United States	Local Institution	National City	California
United States	Local Institution	Oklahoma City	Oklahoma
United States	Local Institution	Pico Rivera	California
United States	Local Institution	Riverside	California
United States	Local Institution	San Diego	California
United States	Local Institution	Shreveport	Louisiana
United States	Local Institution	Tampa	Florida
United States	Local Institution	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Mexico,  Peru,  Russian Federation,  South Africa, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in a mania rating scale at endpoint
Secondary	Response rate and Clinical Global Impression scale at endpoint

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm