Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder
AMETHYST
A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR™) As Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder
2 other identifiers
interventional
3,000
8 countries
168
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Dec 2005
168 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 17, 2006
CompletedFirst Posted
Study publicly available on registry
January 19, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMarch 25, 2009
March 1, 2009
January 17, 2006
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)
Secondary Outcomes (1)
Evaluate quetiapine SR compared to placebo on health related quality of life.
Interventions
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (168)
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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
Related Publications (2)
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.
PMID: 24816198DERIVEDWeisler 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.
PMID: 24175720DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Seroquel Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 17, 2006
First Posted
January 19, 2006
Study Start
December 1, 2005
Study Completion
August 1, 2007
Last Updated
March 25, 2009
Record last verified: 2009-03