Phase 3 /Seroquel SR Acute Mania 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®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

447

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Cerritos, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • Oceanside, California, United States
        • Research Site
      • Pico Rivera, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Santa Ana, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Aventura, Florida, United States
        • Research Site
      • East Bradenton, Florida, United States
        • Research Site
      • Fort Lauderdale, Florida, United States
        • Research Sitew
      • Hollywood, Florida, United States
        • Research Site
      • Leesburg, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Illinois
      • Hoffman Estates, Illinois, United States
        • Research Site
      • Naperville, Illinois, United States
        • Research Site
      • Oak Brook Terrace, Illinois, United States
        • Research Site
    • Indiana
      • Greenwood, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
    • Kansas
      • Newton, Kansas, United States
        • Research Site
      • Wichita, Kansas, United States
        • Research Site
    • Louisiana
      • Lake Charles, Louisiana, United States
        • Research Site
      • New Orleans, Louisiana, United States
        • Research Site
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Rockville, Maryland, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • New Jersey
      • Kenilworth, New Jersey, United States
        • Research Site
      • Willingboro, New Jersey, United States
        • Research Site
    • New York
      • Elmsford, New York, United States
        • Research Site
      • Holliswood, New York, United States
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States
        • Research Site
    • Ohio
      • Beachwood, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Moon Township, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Desoto, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Irving, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Virginia
      • Arlington, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Bellevue, Washington, United States
        • Research Site

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 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.

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
Change from baseline to final visit in the YMRS total score

Secondary Outcome Measures

Outcome Measure
Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Larisa Acevedo, Ph.D, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2007

Study Completion (ACTUAL)

July 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

Other Study ID Numbers

  • D144CC00004

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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