Study of Aripiprazole in Patients With Bipolar I Disorder
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
1 other identifier
interventional
400
16 countries
85
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Typical duration for phase_3
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 23, 2005
CompletedFirst Posted
Study publicly available on registry
November 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedNovember 8, 2013
May 1, 2008
3.2 years
November 23, 2005
November 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to endpoint in a mania rating scale
Secondary Outcomes (1)
Response rate and Clinical Global Impression Scale at endpoint
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of bipolar I disorder, manic or mixed episode
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
Local Institution
Little Rock, Arkansas, United States
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Riverside, California, United States
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Deerfield Beach, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Hoffman Estates, Illinois, United States
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Oak Brook, Illinois, United States
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Newton, Kansas, United States
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Newton, Massachusetts, United States
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New York, New York, United States
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Staten Island, New York, United States
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Raleigh, North Carolina, United States
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Dayton, Ohio, United States
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Media, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Bellevue, Washington, United States
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Epping, Victoria, Australia
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Brno-Bohunice, Czechia
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Hradec Králové, Czechia
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Opava, Czechia
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Prague, Czechia
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Pärnu, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Viljandi Maakond, Estonia
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Voru Maakond, Estonia
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Bordeaux, France
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Dole, France
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Grenoble, France
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Jonzac, France
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La Rochelle, France
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Limoges, France
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Marseille, France
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Nîmes, France
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Pessac, France
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Rennes, France
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Berlin, Germany
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Jena, Germany
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Magdeburg, Germany
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Meunchen, Germany
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Westersted, Germany
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Budapest, Hungary
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Gyula, Hungary
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Kecskemét, Hungary
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Nagykálló, Hungary
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Bassano del Grappa, Italy
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Cagliari, Italy
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Florence, Italy
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Pisa, Italy
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Roma, Italy
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Sassari, Italy
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Trieste, Italy
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Voghera -Pavia, Italy
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Retranchement, Netherlands
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Zaandam, Netherlands
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Choroszcz, Poland
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Kościan, Poland
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Krakow, Poland
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Poznan, Poland
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Torun, Poland
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Tuszyn, Poland
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Lisbon, Portugal
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Leningrad Region, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Smolensk, Russia
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Port Elizabeth, Eastern Cape, South Africa
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Westdene, Free State, South Africa
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Pretoria, Gauteng, South Africa
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Vereeniging, Gauteng, South Africa
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Welkom, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Observatory, Western Cape, South Africa
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Barcelona, Spain
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Madrid, Spain
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Valencia, Spain
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Vitoria-Gasteiz, Spain
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Herisau, Switzerland
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Glasgow, Dumbartonshire, United Kingdom
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London, Greater London, United Kingdom
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Burnley, Lancashire, United Kingdom
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South Wales, Mid Glamorgan, United Kingdom
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Surbiton, Middlesex, United Kingdom
Related Publications (2)
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.
PMID: 18381903BACKGROUNDVieta 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.
PMID: 20429835DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 23, 2005
First Posted
November 24, 2005
Study Start
October 1, 2004
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
November 8, 2013
Record last verified: 2008-05