Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder

NCT ID: NCT00278941

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

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-08-31

Brief Summary

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The purpose of this study is to determine safety \& efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo \& to evaluate quality of sleep, overall quality of life, and effect, if any, on anxiety and satisfaction 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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Major Depressive Disorder

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 Sustained Release

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major Depressive Disorder,
* Single Episode, or 296.3x Major Depressive Disorder,

Exclusion Criteria

* Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment,
* Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patients current psychiatric status.
* Patients whose current episode of depression\>12 months or \<4 weeks from enrollment
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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AstraZeneca Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Birmingham, Alabama, United States

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Tuscaloosa, Alabama, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Cerritos, California, United States

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Costa Mesa, California, United States

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El Centro, California, United States

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Fresno, 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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Oceanside, California, United States

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Pasadena, California, United States

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Pico Rivera, California, United States

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Redlands, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Stanford, California, United States

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Torrance, California, United States

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Upland, California, United States

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Vista, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Pueblo, Colorado, United States

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Cromwell, Connecticut, United States

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Farmington, Connecticut, United States

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Middletown, Connecticut, United States

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Wilmington, Delaware, United States

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

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Altamonte Springs, Florida, United States

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Clearwater, Florida, United States

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Coral Springs, Florida, United States

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DeLand, Florida, United States

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Fort Myers, Florida, United States

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Gainsville, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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North Miami, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Palm Beach Gardens, Florida, United States

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Saint Petersberg, Florida, United States

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Sarasota, Florida, United States

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Stuart, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Columbus, Georgia, United States

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Decatur, Georgia, United States

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Roswell, Georgia, United States

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Sandy Springs, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Chicago, Illinois, United States

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Granite City, Illinois, United States

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Hoffman Estates, Illinois, United States

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Libertyville, Illinois, United States

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Northfield, Illinois, United States

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Skokie, Illinois, United States

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Lafayette, Indiana, United States

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Terre Haute, Indiana, United States

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Valparaiso, Indiana, United States

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Prairie Village, Kansas, United States

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Topeka, Kansas, United States

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Owensboro, Kentucky, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Glen Burnie, Maryland, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Cambridge, Massachusetts, United States

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Fall River, Massachusetts, United States

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Pittsfield, Massachusetts, United States

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Springfield, Massachusetts, United States

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Worcester, Massachusetts, United States

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Bloomfield Hills, Michigan, United States

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Clinton Twp, Michigan, United States

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Farmington Hills, Michigan, United States

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Portage, Michigan, United States

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Rochester Hills, Michigan, United States

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Minneapolis, Minnesota, United States

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Flowood, Mississippi, United States

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Ridgeland, Mississippi, United States

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City of Saint Peters, Missouri, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Kenilworth, New Jersey, United States

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Princeton, New Jersey, United States

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Toms River, New Jersey, United States

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Brooklyn, New York, United States

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Cedarhurst, New York, United States

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Mount Kisco, New York, United States

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New York, New York, United States

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Olean, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Avon Lake, Ohio, United States

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Canton, Ohio, United States

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Chagrin Falls, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Middleburg Heights, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Salem, Oregon, United States

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Allentown, Pennsylvania, United States

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Bala-Cynwyd, Pennsylvania, United States

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Coatesville, Pennsylvania, United States

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Havertown, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Media, Pennsylvania, United States

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Moon Township, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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DeSoto, Texas, United States

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Friendswood, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Midvale, Utah, United States

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Woodstock, Vermont, United States

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Charlottesville, Virginia, United States

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Midlothian, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Vratsa, , Bulgaria

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Miramichi, New Brunswick, Canada

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Burlington, Ontario, Canada

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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Gatineau, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Rio Predia, , Puerto Rico

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Bucharest, , Romania

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Iași, , Romania

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Piteşti, , Romania

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Moscow, , Russia

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Saint Petersburg, , Russia

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Piešťany, , Slovakia

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Prešov, , Slovakia

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Sereď, , Slovakia

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Trenčín, , Slovakia

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Ayrshire, , United Kingdom

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Glasgow, , United Kingdom

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Reading, , United Kingdom

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Countries

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United States Bulgaria Canada Puerto Rico Romania Russia Slovakia United Kingdom

References

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Weisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624.

Reference Type DERIVED
PMID: 24816198 (View on PubMed)

Weisler R, McIntyre RS. The role of extended-release quetiapine fumarate monotherapy in the treatment of patients with major depressive disorder. Expert Rev Neurother. 2013 Nov;13(11):1161-82. doi: 10.1586/14737175.2013.846520.

Reference Type DERIVED
PMID: 24175720 (View on PubMed)

Other Identifiers

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Amethyst

Identifier Type: -

Identifier Source: secondary_id

D1448C00005

Identifier Type: -

Identifier Source: org_study_id

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