Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

NCT ID: NCT00083954

Last Updated: 2013-01-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quetiapine Fumarate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status

Exclusion Criteria

* More than 8 mood episodes in the past year from screen (visit 1);
* A current Axis I disorder other than bipolar disorder within 6 months of screening;
* patients with clinically significant abnormal laboratory findings in the investigator's judgment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

AstraZeneca Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Birmingham, Alabama, United States

Site Status

Research Site

Scottsdale, Arizona, United States

Site Status

Research Site

Cerritos, California, United States

Site Status

Research Site

Garden Grove, California, United States

Site Status

Research Site

San Diego, California, United States

Site Status

Research Site

Torrance, California, United States

Site Status

Research Site

Jacksonville, Florida, United States

Site Status

Research Site

Maitland, Florida, United States

Site Status

Research Site

Orlando, Florida, United States

Site Status

Research Site

Winter Park, Florida, United States

Site Status

Research Site

Boise, Idaho, United States

Site Status

Research Site

Oak Brook, Illinois, United States

Site Status

Research Site

Overbrook Terrace, Illinois, United States

Site Status

Research Site

Shreveport, Louisiana, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Research Site

Clementon, New Jersey, United States

Site Status

Research Site

Moorestown, New Jersey, United States

Site Status

Research Site

Albuquerque, New Mexico, United States

Site Status

Research Site

Brooklyn, New York, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Staten Island, New York, United States

Site Status

Research Site

Raleigh, North Carolina, United States

Site Status

Research Site

Cincinnati, Ohio, United States

Site Status

Research Site

Dayton, Ohio, United States

Site Status

Research Site

Oklahoma City, Oklahoma, United States

Site Status

Research Site

Portland, Oregon, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

Pittsburgh, Pennsylvania, United States

Site Status

Research Site

Charleston, South Carolina, United States

Site Status

Research Site

Memphis, Tennessee, United States

Site Status

Research Site

Austin, Texas, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Salt Lake City, Utah, United States

Site Status

Research Site

Bellevue, Washington, United States

Site Status

Research Site

Kirkland, Washington, United States

Site Status

Research Site

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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

Review additional registry numbers or institutional identifiers associated with this trial.

D1447C00135

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pediatric Bipolar Depression
NCT00811473 COMPLETED PHASE3