Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
676 participants
INTERVENTIONAL
2005-05-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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quetiapine fumarate (Seroquel)
paroxetine
mood stabilizing activity
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed
Exclusion Criteria
* Use of prohibited medication
* Substance or alcohol dependence or abuse
* Current suicide risk or suicide attempt within 6 months
* Breast feeding or pregnancy
* Clinically relevant disease or clinical finding
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Seroquel Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
National City, California, United States
Research Site
San Clemente, California, United States
Research Site
San Diego, California, United States
Research Site
Maitland, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Smyrna, Georgia, United States
Research Site
Northfield, Illinois, United States
Research Site
Oak Brook, Illinois, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Glen Burnie, Maryland, United States
Research Site
St Louis, Missouri, United States
Research Site
Clementon, New Jersey, United States
Research Site
New York, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Irving, Texas, United States
Research Site
Richmond, Virginia, United States
Research Site
Bellevue, Washington, United States
Research Site
Kirkland, Washington, United States
Research Site
Brisbane, Queensland, Australia
Research Site
Everton Park, Queensland, Australia
Research Site
Southport, Queensland, Australia
Research Site
Epping, Victoria, Australia
Research Site
Malvern, Victoria, Australia
Research Site
Providencia Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Bogotá, , Colombia
Research Site
San José, , Costa Rica
Research Site
Athens, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Tripoli, , Greece
Research Site
México, , Mexico
Research Site
Yucatán, , Mexico
Research Site
Lima, , Peru
Research Site
San Borja, , Peru
Research Site
Bucharest, , Romania
Research Site
Galati, , Romania
Research Site
Iași, , Romania
Research Site
Măgura, , Romania
Research Site
Benoni, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Gaziantep, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Manisa, , Turkey (Türkiye)
Countries
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References
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McElroy SL, Weisler RH, Chang W, Olausson B, Paulsson B, Brecher M, Agambaram V, Merideth C, Nordenhem A, Young AH; EMBOLDEN II (Trial D1447C00134) Investigators. A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry. 2010 Feb;71(2):163-74. doi: 10.4088/JCP.08m04942gre. Epub 2010 Jan 26.
Other Identifiers
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D1447C00134
Identifier Type: -
Identifier Source: org_study_id
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