Clinical trial NCT00278941: Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Seroquel SR™
Major Depressive Disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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:
measure: Evaluate quetiapine SR compared to placebo on health related quality of life.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Research Site
state: Alabama
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Cerritos
country: United States
facility: Research Site
state: California
city: Costa Mesa
country: United States
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state: California
city: El Centro
country: United States
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state: California
city: Fresno
country: United States
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state: California
city: La Mesa
country: United States
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state: California
city: Los Angeles
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state: California
city: Oceanside
country: United States
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city: Pasadena
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city: Pico Rivera
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state: California
city: Redlands
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city: Riverside
country: United States
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city: San Diego
country: United States
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city: Santa Ana
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city: Stanford
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city: Torrance
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city: Upland
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state: California
city: Vista
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city: Walnut Creek
country: United States
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city: Colorado Springs
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city: Pueblo
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city: Cromwell
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state: Connecticut
city: Farmington
country: United States
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city: Middletown
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state: Connecticut
city: Wilmington
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state: Delaware
city: Washington
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state: District of Columbia
city: Altamonte Springs
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state: Florida
city: Clearwater
country: United States
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city: Coral Springs
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city: Palm Beach Gardens
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city: St. Petersberg
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city: W Palm Beach
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city: Augusta
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city: Columbus
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city: Decatur
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city: Roswell
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city: Sandy Springs
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city: Coeur D'Alene
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state: Idaho
city: Chicago
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city: Granite City
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city: Hoffman Estates
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city: Libertyville
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city: Northfield
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city: Skokie
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city: Terre Haute
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city: Shreveport
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city: Glen Burnie
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city: Rockville
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city: Boston
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state: Massachusetts
city: Cambridge
country: United States
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city: Fall River
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city: Pittsfield
country: United States
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city: Springfield
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city: Worcester
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city: Bloomfield Hills
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city: Clinton Twp
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city: Farmington Hills
country: United States
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city: Portage
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city: Rochester Hills
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city: Minneapolis
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city: Ridgeland
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city: St Peters
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city: St. Charles
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city: St. Louis
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city: Las Vegas
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city: Cherry Hill
country: United States
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city: Kenilworth
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city: Princeton
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city: Toms River
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city: Brooklyn
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city: Cedarhurst
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city: New York
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city: Olean
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city: Greensboro
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city: Avon Lake
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state: Ohio
city: Canton
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city: Chagrin Falls
country: United States
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city: Cincinnati
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city: Middleburg Heights
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city: Bala Cynwyd
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city: Reading
country: United States
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city: Lincoln
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state: Rhode Island
city: Providence
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city: Charleston
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state: South Carolina
city: Greer
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city: Sioux Falls
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city: Memphis
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state: Tennessee
city: Nashville
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city: Desoto
country: United States
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state: Texas
city: Friendswood
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city: Houston
country: United States
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city: Lake Jackson
country: United States
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city: San Antonio
country: United States
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city: Wichita Falls
country: United States
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state: Texas
city: Midvale
country: United States
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state: Utah
city: Woodstock
country: United States
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state: Vermont
city: Charlottesville
country: United States
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state: Virginia
city: Midlothian
country: United States
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state: Virginia
city: Richmond
country: United States
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state: Virginia
city: Virginia Beach
country: United States
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state: Virginia
city: Spokane
country: United States
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state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Vratza
country: Bulgaria
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Miramichi
country: Canada
facility: Research Site
state: New Brunswick
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Gatineau
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Rio Predia
country: Puerto Rico
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St Petersburg
country: Russian Federation
facility: Research Site
city: Piestany
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Sered
country: Slovakia
facility: Research Site
city: Trencin
country: Slovakia
facility: Research Site
city: Ayrshire
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Seroquel Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.