Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression

NCT ID: NCT00060489

Last Updated: 2011-01-26

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

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-09-30

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.

Detailed Description

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Conditions

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Bipolar Disorder Depression, Bipolar

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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SEROQUEL (quetiapine fumarate) Tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written Informed Consent;
* Bipolar disorder with most recent episode depressed;
* Outpatient status

Exclusion Criteria

* Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening;
* Patients whose current episode of depression exceeds 12 months or is less than 4 weeks
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

Locations

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Birmingham, Alabama, United States

Site Status

Beverly Hills, California, United States

Site Status

La Mesa, California, United States

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San Diego, California, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Smyrna, Georgia, United States

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Oak Brook, Illinois, United States

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Shreveport, Louisiana, United States

Site Status

Clementon, New Jersey, United States

Site Status

Moorestown, New Jersey, 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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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Columbia, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Salt Lake City, Utah, United States

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Falls Church, Virginia, United States

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Bellevue, Washington, United States

Site Status

Kirkland, Washington, United States

Site Status

Countries

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United States

References

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Lydiard RB, Culpepper L, Schioler H, Gustafsson U, Paulsson B. Quetiapine monotherapy as treatment for anxiety symptoms in patients with bipolar depression: a pooled analysis of results from 2 double-blind, randomized, placebo-controlled studies. Prim Care Companion J Clin Psychiatry. 2009;11(5):215-25. doi: 10.4088/PCC.08m00659.

Reference Type DERIVED
PMID: 19956459 (View on PubMed)

Other Identifiers

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5077US/0049

Identifier Type: -

Identifier Source: org_study_id

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