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Trial record 44 of 158 for:    Diseases | ( Map: Costa Rica )

Seroquel in Bipolar Depression Versus SSRI (EMBOLDEN II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00119652
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : January 4, 2013
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Brief Summary:
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Bipolar Depression Depression Drug: quetiapine fumarate (Seroquel) Drug: paroxetine Behavioral: mood stabilizing activity Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 676 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)
Study Start Date : May 2005
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures :
  1. Secondary variables supportive to the primary objective:
  2. MADRS total score response
  3. MADRS total score remission

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female out-patients aged 18 to 65 years inclusive
  • Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed

Exclusion Criteria:

  • Current period of depression lasting less than 4 weeks or more than 12 months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00119652

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United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, Arkansas
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Little Rock, Arkansas, United States
United States, California
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National City, California, United States
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San Clemente, California, United States
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San Diego, California, United States
United States, Florida
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Maitland, Florida, United States
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Winter Park, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
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Smyrna, Georgia, United States
United States, Illinois
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Northfield, Illinois, United States
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Oak Brook, Illinois, United States
United States, Louisiana
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
United States, Maryland
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Glen Burnie, Maryland, United States
United States, Missouri
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St. Louis, Missouri, United States
United States, New Jersey
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Clementon, New Jersey, United States
United States, New York
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New York, New York, United States
United States, North Carolina
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Raleigh, North Carolina, United States
United States, Ohio
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States
United States, Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Irving, Texas, United States
United States, Virginia
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Richmond, Virginia, United States
United States, Washington
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Bellevue, Washington, United States
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Kirkland, Washington, United States
Australia, Queensland
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Brisbane, Queensland, Australia
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Everton Park, Queensland, Australia
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Southport, Queensland, Australia
Australia, Victoria
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Epping, Victoria, Australia
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Malvern, Victoria, Australia
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Providencia Santiago, Chile
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Santiago, Chile
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Bogota, Colombia
Costa Rica
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San Jose, Costa Rica
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Athens, Greece
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Thessaloniki, Greece
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Tripoli, Greece
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Mexico, Mexico
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Yucatan, Mexico
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Lima, Peru
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San Borja, Peru
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Bucharest, Romania
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Galati, Romania
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Iasi, Romania
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Magura, Romania
South Africa
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Benoni, South Africa
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Cape Town, South Africa
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Durban, South Africa
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Pretoria, South Africa
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Gaziantep, Turkey
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Istanbul, Turkey
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Manisa, Turkey
Sponsors and Collaborators
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Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00119652     History of Changes
Other Study ID Numbers: D1447C00134
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
Bipolar disorder
bipolar depression
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Behavioral Symptoms
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors