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Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

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.
 
ClinicalTrials.gov Identifier: NCT00083954
Recruitment Status : Completed
First Posted : June 7, 2004
Last Update Posted : January 4, 2013
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Quetiapine Fumarate Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression
Study Start Date : June 2004
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder




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

Secondary Outcome Measures :
  1. Evaluate the incidence of treatment-emergent mania compared to placebo


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
Criteria

Inclusion Criteria:

  • Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status

Exclusion Criteria:

  • More than 8 mood episodes in the past year from screen (visit 1);
  • A current Axis I disorder other than bipolar disorder within 6 months of screening;
  • patients with clinically significant abnormal laboratory findings in the investigator's judgment

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 ClinicalTrials.gov identifier (NCT number): NCT00083954


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, Arizona
Research Site
Scottsdale, Arizona, United States
United States, California
Research Site
Cerritos, California, United States
Research Site
Garden Grove, California, United States
Research Site
San Diego, California, United States
Research Site
Torrance, California, United States
United States, Florida
Research Site
Jacksonville, Florida, United States
Research Site
Maitland, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Winter Park, Florida, United States
United States, Idaho
Research Site
Boise, Idaho, United States
United States, Illinois
Research Site
Oak Brook, Illinois, United States
Research Site
Overbrook Terrace, Illinois, United States
United States, Louisiana
Research Site
Shreveport, Louisiana, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, New Jersey
Research Site
Clementon, New Jersey, United States
Research Site
Moorestown, New Jersey, United States
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States
United States, New York
Research Site
Brooklyn, New York, United States
Research Site
New York, New York, United States
Research Site
Staten Island, New York, United States
United States, North Carolina
Research Site
Raleigh, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
United States, Texas
Research Site
Austin, Texas, United States
Research Site
Houston, Texas, United States
United States, Utah
Research Site
Salt Lake City, Utah, United States
United States, Washington
Research Site
Bellevue, Washington, United States
Research Site
Kirkland, Washington, United States
Research Site
Seattle, Washington, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00083954    
Other Study ID Numbers: D1447C00135
First Posted: June 7, 2004    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
Bipolar I Disorder
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs