Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder
NCT ID: NCT00388973
Last Updated: 2010-04-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
338 participants
INTERVENTIONAL
2006-09-30
2007-12-31
Brief Summary
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PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Quetiapine
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Uncontrolled hypertension, substance or alcohol abuse
* A current diagnosis of cancer or a current or past diagnosis of stroke
66 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca Pharmaceuticals
Principal Investigators
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Catherine Datto, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
San Diego, California, United States
Research Site
Fort Myers, Florida, United States
Research Site
Gainsville, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Roswell, Georgia, United States
Research Site
Boston, Massachusetts, United States
Research Site
Brooklyn, New York, United States
Research Site
Eugene, Oregon, United States
Research Site
Jenkintown, Pennsylvania, United States
Research Site
Memphis, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
City Bell, Buenos Aires, Argentina
Research Site
La Plata, Buenos Aires, Argentina
Research Site
Córdoba, Córdoba Province, Argentina
Research Site
Mendoza, Mendoza Province, Argentina
Research Site
Buenos Aires, , Argentina
Research Site
Capital Federal, , Argentina
Research Site
Tartu, Estonia, Estonia
Research Site
Tallinn, , Estonia
Research Site
Viljandi, , Estonia
Research Site
Helsinki, Finland, Finland
Research Site
Tampere, Finland, Finland
Research Site
Järvenpää, , Finland
Research Site
Kuopio, , Finland
Research Site
Salo, , Finland
Research Site
Seinäjoki, , Finland
Research Site
Arkhangelsk, , Russia
Research Site
Izhevsk, , Russia
Research Site
Lipetsk, , Russia
Research Site
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Perm, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Stavropol, , Russia
Research Site
Hlevakha, Kyiv Oblast, Ukraine
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Donetsk, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Luhansk, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Vinnitsa, , Ukraine
Countries
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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.
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.
Montgomery SA, Altamura AC, Katila H, Datto C, Szamosi J, Eriksson H. Efficacy of extended release quetiapine fumarate monotherapy in elderly patients with major depressive disorder: secondary analyses in subgroups of patients according to baseline anxiety, sleep disturbance, and pain levels. Int Clin Psychopharmacol. 2014 Mar;29(2):93-105. doi: 10.1097/YIC.0000000000000007.
Locklear JC, Svedsater H, Datto C, Endicott J. Effects of once-daily extended release quetiapine fumarate (quetiapine XR) on quality of life and sleep in elderly patients with major depressive disorder. J Affect Disord. 2013 Jul;149(1-3):189-95. doi: 10.1016/j.jad.2013.01.021. Epub 2013 Apr 29.
Katila H, Mezhebovsky I, Mulroy A, Berggren L, Eriksson H, Earley W, Datto C. Randomized, double-blind study of the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder. Am J Geriatr Psychiatry. 2013 Aug;21(8):769-84. doi: 10.1016/j.jagp.2013.01.010. Epub 2013 Feb 6.
Other Identifiers
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EUDRACT No: 2006-001196-38
Identifier Type: -
Identifier Source: secondary_id
D1448C00014
Identifier Type: -
Identifier Source: org_study_id
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