- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00422214
Phase III/Seroquel SR Bipolar Depression Monotherapy - US
March 24, 2009 updated by: AstraZeneca
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
400
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
- Research Site
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Arizona
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Phoenix, Arizona, United States
- Research Site
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Scottsdale, Arizona, United States
- Research Site
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Arkansas
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Little Rock, Arkansas, United States
- Research Site
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California
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Cerritos, California, United States
- Research Site
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La Mesa, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Oceanside, California, United States
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Pico Rivera, California, United States
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San Diego, California, United States
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Wildomar, California, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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Bradenton, Florida, United States
- Research Site
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Maitland, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Georgia
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Smyrna, Georgia, United States
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Hawaii
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Honolulu, Hawaii, United States
- Research Site
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Illinois
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Joliet, Illinois, United States
- Research Site
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Indiana
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Greenwood, Indiana, United States
- Research Site
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Indianapolis, Indiana, United States
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Kansas
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Wichita, Kansas, United States
- Research Site
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Louisiana
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Shreveport, Louisiana, United States
- Research Site
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Maryland
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Rockville, Maryland, United States
- Research Site
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Michigan
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Farmington Hills, Michigan, United States
- Research Site
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Missouri
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St. Louis, Missouri, United States
- Research Site
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New Jersey
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Cherry Hill, New Jersey, United States
- Research Site
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Clementon, New Jersey, United States
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New York
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Brooklyn, New York, 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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Ohio
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
- Research Site
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Oregon
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Portland, Oregon, United States
- Research Site
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Salem, Oregon, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
- Research Site
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Tennessee
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Memphis, Tennessee, United States
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Texas
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Dallas, Texas, United States
- Research Site
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Houston, Texas, United States
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Virginia
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Charlottesville, Virginia, United States
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Virginia Beach, Virginia, United States
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Washington
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Bellevue, Washington, United States
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Seattle, Washington, United States
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South Kirkland, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of written informed consent
- Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
- Outpatient status at enrollment
Exclusion Criteria:
- Patients with >8 mood episodes during the past 12 years
- Use of prohibited medications
- Substance or alcohol abuse or dependence
- Current suicide risk or suicide attempt within last 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline in depression symptoms by final visit as measured by the MADRS total score
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Secondary Outcome Measures
Outcome Measure |
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Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Larisa Acevedo, Ph.D, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Study Completion (ACTUAL)
June 1, 2007
Study Registration Dates
First Submitted
January 12, 2007
First Submitted That Met QC Criteria
January 12, 2007
First Posted (ESTIMATE)
January 15, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
March 25, 2009
Last Update Submitted That Met QC Criteria
March 24, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Nervous System Diseases
- Mood Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Schizophrenia Spectrum and Other Psychotic Disorders
- Bipolar and Related Disorders
- Depression
- Depressive Disorder
- Psychotic Disorders
- Mental Disorders
- Bipolar Disorder
- Mania
- Affective Disorders, Psychotic
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- D144CC00002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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