Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
NCT ID: NCT00351169
Last Updated: 2008-12-22
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
450 participants
INTERVENTIONAL
2006-05-31
2007-06-30
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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Quetiapine SR
Escitalopram
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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Willie Earley, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Edmonton, Alberta, Canada
Research Site
Kelowna, British Columbia, Canada
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Penticton, British Columbia, Canada
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Vancouver, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Sydney, Nova Scotia, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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HA Erbing, , China
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Nanjing, , China
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Shanghai, , China
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Wuhan, , China
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Helsinki, , Finland
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Oulu, , Finland
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Tampere, , Finland
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Turku, , Finland
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Johor Bahru, , Malaysia
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Perak, , Malaysia
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Petaling Jaya, , Malaysia
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Aguascalientes, , Mexico
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Distrito Federal, , Mexico
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Guadalajara, , Mexico
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Cebu City, , Philippines
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Davao City, , Philippines
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Mandaluyong, , Philippines
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Manila, , Philippines
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Benoni, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Johannesburg, , South Africa
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Krugersdorp, , South Africa
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Seoul, , South Korea
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Langreo, , Spain
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Vigo, , Spain
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Zamora, , Spain
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. 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.
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.
Trivedi MH, Bandelow B, Demyttenaere K, Papakostas GI, Szamosi J, Earley W, Eriksson H. Evaluation of the effects of extended release quetiapine fumarate monotherapy on sleep disturbance in patients with major depressive disorder: a pooled analysis of four randomized acute studies. Int J Neuropsychopharmacol. 2013 Sep;16(8):1733-44. doi: 10.1017/S146114571300028X. Epub 2013 May 14.
Thase ME, Montgomery S, Papakostas GI, Bauer M, Trivedi MH, Svedsater H, Locklear JC, Gustafsson U, Datto C, Eriksson H. Quetiapine XR monotherapy in major depressive disorder: a pooled analysis to assess the influence of baseline severity on efficacy. Int Clin Psychopharmacol. 2013 May;28(3):113-20. doi: 10.1097/YIC.0b013e32835fb971.
Other Identifiers
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AMBER
Identifier Type: -
Identifier Source: secondary_id
EUDRACT No: 2005-005052-40
Identifier Type: -
Identifier Source: secondary_id
D1448C00004
Identifier Type: -
Identifier Source: org_study_id