Phase III/Seroquel SR Bipolar Depression Monotherapy - US

NCT ID: NCT00422214

Last Updated: 2009-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Affective Psychosis, Bipolar Depression, Bipolar Manic-Depressive Psychosis Psychoses, Manic-Depressive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Quetiapine fumarate (Seroquel) SR

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Catherine Datto, MD

Role: STUDY_DIRECTOR

AstraZeneca

Larisa Acevedo, Ph.D

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Cerritos, California, United States

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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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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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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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Smyrna, Georgia, United States

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Honolulu, Hawaii, United States

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Joliet, Illinois, United States

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Greenwood, Indiana, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Shreveport, Louisiana, United States

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Rockville, Maryland, United States

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Farmington Hills, Michigan, United States

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St Louis, Missouri, United States

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Cherry Hill, New Jersey, United States

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Clementon, New Jersey, United States

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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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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 City, Oklahoma, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Charlottesville, Virginia, United States

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Virginia Beach, Virginia, United States

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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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Countries

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United States

Other Identifiers

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D144CC00002

Identifier Type: -

Identifier Source: org_study_id

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