Clinical trial NCT00257972: Study of Aripiprazole in Patients With Bipolar I Disorder
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
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: 2005-11-24
Enrollment: 400
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 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.


Eligibility criteria: 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

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: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Riverside
country: United States
facility: Local Institution
state: California
city: Deerfield Beach
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Maitland
country: United States
facility: Local Institution
state: Florida
city: Hoffman Estates
country: United States
facility: Local Institution
state: Illinois
city: Oakbrook
country: United States
facility: Local Institution
state: Illinois
city: Newton
country: United States
facility: Local Institution
state: Kansas
city: Newton
country: United States
facility: Local Institution
state: Massachusetts
city: New York
country: United States
facility: Local Institution
state: New York
city: Staten Island
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: Norristown
country: United States
facility: Local Institution
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Columbia
country: United States
facility: Local Institution
state: South Carolina
city: Memphis
country: United States
facility: Local Institution
state: Tennessee
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Bellevue
country: United States
facility: Local Institution
state: Washington
city: Epping
country: Australia
facility: Local Institution
state: Victoria
city: Rousse
country: Bulgaria
facility: Local Institution
city: Sofia
country: Bulgaria
facility: Local Institution
city: Varna
country: Bulgaria
facility: Local Institution
city: Brno - Bohunice
country: Czech Republic
facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Opava
country: Czech Republic
facility: Local Institution
city: Praha 2
country: Czech Republic
facility: Local Institution
city: Parnu
country: Estonia
facility: Local Institution
city: Tallinn
country: Estonia
facility: Local Institution
city: Tartu
country: Estonia
facility: Local Institution
city: Viljandi Maakond
country: Estonia
facility: Local Institution
city: Voru Maakond
country: Estonia
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Dole
country: France
facility: Local Institution
city: Grenoble
country: France
facility: Local Institution
city: Jonzac Cedex
country: France
facility: Local Institution
city: La Rochelle Cedex 1
country: France
facility: Local Institution
city: Limoges Cedex
country: France
facility: Local Institution
city: Marseille Cedex 05
country: France
facility: Local Institution
city: Nimes
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: Rennes Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Jena
country: Germany
facility: Local Institution
city: Magdeburg
country: Germany
facility: Local Institution
city: Meunchen
country: Germany
facility: Local Institution
city: Westersted
country: Germany
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Gyula
country: Hungary
facility: Local Institution
city: Kecskemet
country: Hungary
facility: Local Institution
city: Nagykallo
country: Hungary
facility: Local Institution
city: Bassano Del Grappa
country: Italy
facility: Local Institution
city: Cagliari
country: Italy
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Sassari
country: Italy
facility: Local Institution
city: Trieste
country: Italy
facility: Local Institution
city: Voghera -Pavia
country: Italy
facility: Local Institution
city: Retranchement
country: Netherlands
facility: Local Institution
city: Zaandam
country: Netherlands
facility: Local Institution
city: Choroszcz
country: Poland
facility: Local Institution
city: Koscian
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Torun
country: Poland
facility: Local Institution
city: Tuszyn
country: Poland
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Lisbon
country: Portugal
facility: Local Institution
city: Leningrad Region
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Smolensk
country: Russian Federation
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern Cape
city: Westdene
country: South Africa
facility: Local Institution
state: Free State
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Vereeniging
country: South Africa
facility: Local Institution
state: Gauteng
city: Welkom
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Observatory
country: South Africa
facility: Local Institution
state: Western Cape
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Vitoria
country: Spain
facility: Local Institution
city: Herisau
country: Switzerland
facility: Local Institution
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Dumbartonshire
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Burnley
country: United Kingdom
facility: Local Institution
state: Lancashire
city: South Wales
country: United Kingdom
facility: Local Institution
state: Mid Glamorgan
city: Surbiton
country: United Kingdom
facility: Local Institution
state: Middlesex
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Vieta E, Owen R, Baudelet C, McQuade RD, Sanchez R, Marcus RN. Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study. Curr Med Res Opin. 2010 Jun;26(6):1485-96. doi: 10.1185/03007991003779380.