Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
AMBER
A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder
3 other identifiers
interventional
450
9 countries
42
Brief Summary
To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of 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
42 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 11, 2006
CompletedFirst Posted
Study publicly available on registry
July 12, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedDecember 22, 2008
December 1, 2007
July 11, 2006
December 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of quetiapine SR compared with placebo in the treatment of patients with major depressive disorder (MDD) as assessed by change from randomisation to week 8 score in the MADRS total score.
Secondary Outcomes (1)
If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo
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 (42)
Research Site
Edmonton, Alberta, Canada
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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
Related Publications (6)
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. 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.
PMID: 24175720DERIVEDClayton 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: 24067192DERIVEDTrivedi 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.
PMID: 23673347DERIVEDThase 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.
PMID: 23485955DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Willie Earley, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 11, 2006
First Posted
July 12, 2006
Study Start
May 1, 2006
Study Completion
June 1, 2007
Last Updated
December 22, 2008
Record last verified: 2007-12