Study of Aripiprazole in Patients With Bipolar I Disorder

Bipolar Disorder Clinical Trial

Official title:

Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257972
• Other study ID #: CN138-134
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2005
• Last updated: November 7, 2013
• Start date: October 2004
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• 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 compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of bipolar I disorder, manic or mixed episode

Exclusion Criteria:

• First manic or mixed episode

• Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole

• Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole

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:
• aripiprazole

Locations

Country	Name	City	State
Australia	Local Institution	Epping	Victoria
Bulgaria	Local Institution	Rousse
Bulgaria	Local Institution	Sofia
Bulgaria	Local Institution	Varna
Czech Republic	Local Institution	Brno - Bohunice
Czech Republic	Local Institution	Hradec Kralove
Czech Republic	Local Institution	Opava
Czech Republic	Local Institution	Praha 2
Estonia	Local Institution	Parnu
Estonia	Local Institution	Tallinn
Estonia	Local Institution	Tartu
Estonia	Local Institution	Viljandi Maakond
Estonia	Local Institution	Voru Maakond
France	Local Institution	Bordeaux
France	Local Institution	Dole
France	Local Institution	Grenoble
France	Local Institution	Jonzac Cedex
France	Local Institution	La Rochelle Cedex 1
France	Local Institution	Limoges Cedex
France	Local Institution	Marseille Cedex 05
France	Local Institution	Nimes
France	Local Institution	Pessac
France	Local Institution	Rennes Cedex
Germany	Local Institution	Berlin
Germany	Local Institution	Jena
Germany	Local Institution	Magdeburg
Germany	Local Institution	Meunchen
Germany	Local Institution	Westersted
Hungary	Local Institution	Budapest
Hungary	Local Institution	Gyula
Hungary	Local Institution	Kecskemet
Hungary	Local Institution	Nagykallo
Italy	Local Institution	Bassano Del Grappa
Italy	Local Institution	Cagliari
Italy	Local Institution	Firenze
Italy	Local Institution	Pisa
Italy	Local Institution	Roma
Italy	Local Institution	Sassari
Italy	Local Institution	Trieste
Italy	Local Institution	Voghera -Pavia
Netherlands	Local Institution	Retranchement
Netherlands	Local Institution	Zaandam
Poland	Local Institution	Choroszcz
Poland	Local Institution	Koscian
Poland	Local Institution	Krakow
Poland	Local Institution	Poznan
Poland	Local Institution	Torun
Poland	Local Institution	Tuszyn
Portugal	Local Institution	Lisboa
Portugal	Local Institution	Lisbon
Russian Federation	Local Institution	Leningrad Region
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	Smolensk
South Africa	Local Institution	Durban	Kwa Zulu Natal
South Africa	Local Institution	Observatory	Western Cape
South Africa	Local Institution	Port Elizabeth	Eastern Cape
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Vereeniging	Gauteng
South Africa	Local Institution	Welkom	Gauteng
South Africa	Local Institution	Westdene	Free State
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Valencia
Spain	Local Institution	Vitoria
Switzerland	Local Institution	Herisau
United Kingdom	Local Institution	Burnley	Lancashire
United Kingdom	Local Institution	Glasgow	Dumbartonshire
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	South Wales	Mid Glamorgan
United Kingdom	Local Institution	Surbiton	Middlesex
United States	Local Institution	Austin	Texas
United States	Local Institution	Bellevue	Washington
United States	Local Institution	Columbia	South Carolina
United States	Local Institution	Dayton	Ohio
United States	Local Institution	Deerfield Beach	Florida
United States	Local Institution	Hoffman Estates	Illinois
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Little Rock	Arkansas
United States	Local Institution	Maitland	Florida
United States	Local Institution	Media	Pennsylvania
United States	Local Institution	Memphis	Tennessee
United States	Local Institution	New York	New York
United States	Local Institution	Newton	Kansas
United States	Local Institution	Newton	Massachusetts
United States	Local Institution	Norristown	Pennsylvania
United States	Local Institution	Oakbrook	Illinois
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Raleigh	North Carolina
United States	Local Institution	Riverside	California
United States	Local Institution	Staten Island	New York

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Czech Republic,  Estonia,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

Vieta E, T'joen C, McQuade RD, Carson WH Jr, Marcus RN, Sanchez R, Owen R, Nameche L. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry. 2008 Oct;165(10):1316-25. doi: 10.1176/appi.ajp.2008.07101560. Epub 2008 Apr 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint in a mania rating scale
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