Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
ONYX
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment
3 other identifiers
interventional
494
12 countries
72
Brief Summary
To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder. 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 P50-P75 for phase_3 major-depressive-disorder
Started May 2006
Shorter than P25 for phase_3 major-depressive-disorder
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 12, 2006
CompletedFirst Posted
Study publicly available on registry
July 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJanuary 26, 2011
January 1, 2011
July 12, 2006
January 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate the efficacy of quetiapine fumarate sustained release
(Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.
Secondary Outcomes (1)
If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female aged 18 to 65 years
- A documented diagnosis of major depressive disorder
You may not qualify if:
- Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (72)
Research Site
Everton Park, Queensland, Australia
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Southport, Queensland, Australia
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Frankston, Victoria, Australia
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Malvern, Victoria, Australia
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Prahran, Victoria, Australia
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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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Jarvenpaa, 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
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Flekkefjord, Norway
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Fyllingsdalen, Norway
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Hamar, Norway
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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
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Durban, KwaZulu-Natal, South Africa
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Cape Town, Western Cape, South Africa
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Falköping, Sweden
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Gothenburg, Sweden
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Halmstad, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
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Trollhättan, Sweden
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Uppsala, Sweden
Related Publications (8)
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.
PMID: 26474010DERIVEDWeisler 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, 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.
PMID: 24175721DERIVEDBauer 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.
PMID: 24108148DERIVEDClayton 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.
PMID: 24067192DERIVEDBauer 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.
PMID: 23672772DERIVEDVieta 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.
PMID: 23497790DERIVEDBauer 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.
PMID: 19358791DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Seroquel Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 12, 2006
First Posted
July 13, 2006
Study Start
May 1, 2006
Study Completion
April 1, 2007
Last Updated
January 26, 2011
Record last verified: 2011-01