Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)
1 other identifier
interventional
710
18 countries
166
Brief Summary
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2004
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 7, 2005
CompletedFirst Posted
Study publicly available on registry
April 8, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedMarch 25, 2009
March 1, 2009
April 7, 2005
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
Secondary Outcomes (1)
Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event
Interventions
Eligibility Criteria
You may qualify if:
- A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
- At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
- Able to understand and comply with the requirements of the study.
You may not qualify if:
- Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
- Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
- Previously randomized into this study or D1447C00126
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (166)
Research Site
Birmingham, Alabama, United States
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Beverly Hills, California, United States
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Chula Vista, California, United States
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Redlands, California, United States
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San Francisco, California, United States
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Santa Ana, California, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Granite City, Illinois, United States
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Libertyville, Illinois, United States
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Schaumburg, Illinois, United States
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Wichita, Kansas, United States
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Metairie, Louisiana, United States
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Glen Burnie, Maryland, United States
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Kalamazoo, Michigan, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Brooklyn, New York, United States
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Olean, New York, United States
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Rochester, New York, United States
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Morganton, North Carolina, United States
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Raleigh, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Havertown, Pennsylvania, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Conroe, Texas, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Greenwich, New South Wales, Australia
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Brisbane, Queensland, Australia
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Everton Park, Queensland, Australia
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Southport, Queensland, Australia
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Glenside, South Australia, Australia
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Box Hill, Victoria, Australia
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Dandenong, Victoria, Australia
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Epping, Victoria, Australia
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Richmond, Victoria, Australia
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Assebroek, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Kortenberg, Belgium
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Manage, Belgium
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St-Denijs-Westrem, Belgium
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Waregem, Belgium
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Kardzhali, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Jeseník, Czechia
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Litomolice, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Pterova, Czechia
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Espoo, Finland
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Harjavalta, Finland
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Helsinki, Finland
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Kellokoski, Finland
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Seinäjoki, Finland
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Besançon, France
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Bourg-en-Bresse, France
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La Rochelle, France
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Marseille, France
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Montpellier, France
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Nîmes, France
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Paris, France
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Strasbourg, France
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Toulouse, France
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Augsburg, Germany
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Berlin, Germany
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Cologne, Germany
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Heidelberg, Germany
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Homburg, Germany
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München, Germany
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Regensburg, Germany
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Saarbrücken, Germany
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Budapest, Hungary
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Füzesabony, Hungary
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Győr, Hungary
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Kecskemét, Hungary
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Kistarcsa, Hungary
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Pécs, Hungary
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Bari, Italy
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Bergamo, Italy
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Brescia, Italy
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Cagliari, Italy
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Civitanova Marche, Italy
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Florence, Italy
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Genova, Italy
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La Spezia, Italy
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Milan, Italy
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Napoli, Italy
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Padua, Italy
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Pisa, Italy
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Roma, Italy
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Siena, Italy
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Trieste, Italy
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Bergen, Norway
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Bodø, Norway
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Bryne, Norway
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Namsos, Norway
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Oslo, Norway
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Ottestad, Norway
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Skien, Norway
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Bialystok, Poland
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Bydgoszcz, Poland
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Choroszcz, Poland
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Gdansk, Poland
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Gorlice, Poland
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Janów Lubelski, Poland
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Krakow, Poland
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Lipno, Poland
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Lodz, Poland
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Lublin, Poland
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Nowy Targ, Poland
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Poznan, Poland
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Starogard Gdański, Poland
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Szczecin, Poland
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Torun, Poland
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Warsaw, Poland
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Zubki, Poland
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Moscow, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Bloemfontein, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Krugersdorp, South Africa
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Pretoria, South Africa
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Barcelona, Barcelona, Spain
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Terrassa, Barcelona, Spain
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Puerto Real, Cádiz, Spain
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Granada, Granada, Spain
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Madrid, Madrid, Spain
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Oviedo, Oviedo, Spain
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Langreo, Principality of Asturias, Spain
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Oviedo, Principality of Asturias, Spain
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Seville, Sevilla, Spain
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Bilbao, Spain
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Guadalajara, Spain
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Santiago de Compostela, Spain
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Vigo, Spain
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Falköping, Sweden
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Linköping, Sweden
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Ludvika, Sweden
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Sollentuna, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Birmingham, United Kingdom
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London, United Kingdom
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Oxford, United Kingdom
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Runcorn, United Kingdom
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Ryhope, United Kingdom
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Surbiton, United Kingdom
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Welwyn Garden City, United Kingdom
Related Publications (1)
Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.
PMID: 23761037DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Seroquel Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 7, 2005
First Posted
April 8, 2005
Study Start
April 1, 2004
Study Completion
October 1, 2006
Last Updated
March 25, 2009
Record last verified: 2009-03