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Phase 3 /Seroquel SR Acute Mania Monotherapy - US

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: January 12, 2007
Last updated: March 24, 2009
Last verified: March 2009

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 Mania for 3 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Condition Intervention Phase
Affective Psychosis, Bipolar
Manic Disorder
Manic-Depressive Psychosis
Manic State
Psychoses, Manic-Depressive
Drug: Quetiapine fumarate (Seroquel) SR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from baseline to final visit in the YMRS total score

Secondary Outcome Measures:
  • Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.

Enrollment: 447
Study Start Date: January 2007
Study Completion Date: July 2007

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

Inclusion Criteria:

  • Provision of written informed consent
  • Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
  • Inpatient hospital admission for the first 4 days of study treatment

Exclusion Criteria:

  • >8 mood episodes within the last 12 months
  • Use of prohibited medication
  • Substance or alcohol abuse or dependence
  • Current suicide risk or suicide attempt within last 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00422123

  Hide Study Locations
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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Cerritos, California, United States
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Garden Grove, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Washington, District of Columbia, United States
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Aventura, Florida, United States
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East Bradenton, Florida, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Hoffman Estates, Illinois, United States
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Naperville, Illinois, United States
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Oak Brook Terrace, Illinois, United States
United States, Indiana
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Greenwood, Indiana, United States
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Indianapolis, Indiana, United States
United States, Kansas
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Newton, Kansas, United States
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Wichita, Kansas, United States
United States, Louisiana
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Lake Charles, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
United States, Maryland
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Rockville, Maryland, United States
United States, Missouri
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St. Louis, Missouri, United States
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Durham, North Carolina, United States
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Beachwood, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Moon Township, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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United States, Virginia
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Arlington, Virginia, United States
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Richmond, Virginia, United States
United States, Washington
Research Site
Bellevue, Washington, United States
Sponsors and Collaborators
Study Director: Catherine Datto, MD AstraZeneca
Study Director: Larisa Acevedo, Ph.D AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00422123     History of Changes
Other Study ID Numbers: D144CC00004
Study First Received: January 12, 2007
Last Updated: March 24, 2009

Keywords provided by AstraZeneca:
Bipolar Disorder
Bipolar Mania
Manic Depression
Seroquel SR
quetiapine fumarate

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Bipolar Disorder
Affective Disorders, Psychotic
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 25, 2017