Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
NCT ID: NCT00351910
Last Updated: 2011-01-26
Study Results
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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COMPLETED
PHASE3
494 participants
INTERVENTIONAL
2006-05-31
2007-04-30
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
QUADRUPLE
Interventions
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Quetiapine
Amitriptyline
Bupropion
Citalopram
Duloxetine
Escitalopram
Fluoxetine
Paroxetine
Sertraline
Venlafaxine
Eligibility Criteria
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Inclusion Criteria
* A documented diagnosis of major depressive disorder
Exclusion Criteria
* Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status
* Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Seroquel Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Everton Park, Queensland, Australia
Research Site
Southport, Queensland, Australia
Research Site
Frankston, Victoria, Australia
Research Site
Malvern, Victoria, Australia
Research Site
Prahran, Victoria, Australia
Research Site
Richmond, Victoria, Australia
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Brisbane, , Australia
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Assebroek, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Kortrijk, , Belgium
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Liège, , Belgium
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Mechelen, , Belgium
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Tielt, , Belgium
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Edmonton, Alberta, Canada
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Moncton, New Brunswick, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Toronto, Ontario, Canada
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Pointe-Claire, Quebec, Canada
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Brno, , Czechia
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Havířov, , Czechia
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Havlíčkův Brod, , Czechia
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Nové Město nad Metují, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Helsinki, , Finland
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Järvenpää, , Finland
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Salo, , Finland
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Turku, , Finland
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Angoulême, , France
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Arcachon, , France
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Caen, , France
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Château-Gontier, , France
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Élancourt, , France
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Le Pecq, , France
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Nîmes, , France
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Paris, , France
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Rennes, , France
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Toulouse, , France
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Augsburg, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Münster, , Germany
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Bergen, , Norway
Research Site
Flekkefjord, , Norway
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Fyllingsdalen, , Norway
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Hamar, , Norway
Research Site
Lysaker, , Norway
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Oslo, , Norway
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Skien, , Norway
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Gdansk, , Poland
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Lodz, , Poland
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Nowy Targ, , Poland
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Szczecin, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Bucharest, , Romania
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Piteşti, , Romania
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Pretoria, Gauteng, South Africa
Research Site
Durban, KwaZulu-Natal, South Africa
Research Site
Cape Town, Western Cape, South Africa
Research Site
Falköping, , Sweden
Research Site
Gothenburg, , Sweden
Research Site
Halmstad, , Sweden
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Malmo, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Sundsvall, , Sweden
Research Site
Trollhättan, , Sweden
Research Site
Uppsala, , Sweden
Countries
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References
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McIntyre RS, Gorwood P, Thase ME, Liss C, Desai D, Chen J, Bauer M. Early Symptom Improvement as a Predictor of Response to Extended Release Quetiapine in Major Depressive Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):706-10. doi: 10.1097/JCP.0000000000000416.
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, Bauer M. Extended-release quetiapine fumarate in the treatment of patients with major depressive disorder: adjunct therapy. Expert Rev Neurother. 2013 Nov;13(11):1183-200. doi: 10.1586/14737175.2013.846519.
Bauer M, Demyttenaere K, El-Khalili N, Thase ME, Papakostas GI, Szamosi J, Earley WR, Eriksson H. Pooled analysis of adjunct extended-release quetiapine fumarate in patients with major depressive disorder according to ongoing SSRI or SNRI treatment. Int Clin Psychopharmacol. 2014 Jan;29(1):16-25. doi: 10.1097/YIC.0000000000000011.
Clayton AH, Locklear JC, Svedsater H, McIntyre RS. Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate. CNS Spectr. 2014 Apr;19(2):182-96. doi: 10.1017/S1092852913000631. Epub 2013 Sep 25.
Bauer M, McIntyre RS, Szamosi J, Eriksson H. Evaluation of adjunct extended-release quetiapine fumarate on sleep disturbance and quality in patients with major depressive disorder and an inadequate response to on-going antidepressant therapy. Int J Neuropsychopharmacol. 2013 Sep;16(8):1755-65. doi: 10.1017/S146114571300031X. Epub 2013 May 14.
Vieta E, Bauer M, Montgomery S, McIntyre RS, Szamosi J, Earley WR, Eriksson H. Pooled analysis of sustained response rates for extended release quetiapine fumarate as monotherapy or adjunct to antidepressant therapy in patients with major depressive disorder. J Affect Disord. 2013 Sep 5;150(2):639-43. doi: 10.1016/j.jad.2013.01.052. Epub 2013 Mar 14.
Bauer M, Pretorius HW, Constant EL, Earley WR, Szamosi J, Brecher M. Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double-blind study. J Clin Psychiatry. 2009 Apr;70(4):540-9. doi: 10.4088/jcp.08m04629. Epub 2009 Apr 7.
Other Identifiers
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ONYX
Identifier Type: -
Identifier Source: secondary_id
EUDRACT No: 2005-0055053-22
Identifier Type: -
Identifier Source: secondary_id
D1448C00007
Identifier Type: -
Identifier Source: org_study_id
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