Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders
OPAL
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR®) as Mono-Therapy in the Treatment of Adult Patients With Major Depressive Disorder
2 other identifiers
interventional
310
1 country
34
Brief Summary
The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders 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 P25-P50 for phase_3 major-depressive-disorder
Started Apr 2006
Shorter than P25 for phase_3 major-depressive-disorder
34 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
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 15, 2006
CompletedFirst Posted
Study publicly available on registry
May 16, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMarch 25, 2009
March 1, 2009
May 15, 2006
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score
Secondary Outcomes (2)
To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo
To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo
Interventions
Eligibility Criteria
You may qualify if:
- Patient is able to provide written informed consent before beginning any study related procedures
- Patient has a documented clinical diagnosis of major depressive disorder
- Patient is able to understand and comply with the requirements of the study, as judged by a study investigator
You may not qualify if:
- Patients with a history of non-compliance as judged by the study investigator
- Patients with a known lack of response to previous treatment with quetiapine
- Patients who have participated in a clinical trial within 4 weeks of randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Research Site
Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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El Centro, California, United States
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Garden Grove, California, United States
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National City, California, United States
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Riverside, California, United States
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Hartford, Connecticut, United States
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Wilmington, Delaware, United States
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Altamonte Springs, Florida, United States
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DeLand, Florida, United States
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Maitland, Florida, United States
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New Port Richey, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Roswell, Georgia, United States
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Naperville, Illinois, United States
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Owensboro, Kentucky, United States
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New Orleans, Louisiana, United States
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Braintree, Massachusetts, United States
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Cambridge, Massachusetts, United States
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Pittsfield, Massachusetts, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Staten Island, New York, United States
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Avon Lake, Ohio, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Allentown, Pennsylvania, United States
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Memphis, Tennessee, United States
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DeSoto, Texas, United States
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Houston, Texas, United States
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: 24067192DERIVEDThase 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: 23485955DERIVEDBortnick B, El-Khalili N, Banov M, Adson D, Datto C, Raines S, Earley W, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in major depressive disorder: a placebo-controlled, randomized study. J Affect Disord. 2011 Jan;128(1-2):83-94. doi: 10.1016/j.jad.2010.06.031. Epub 2010 Aug 6.
PMID: 20691481DERIVED
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 15, 2006
First Posted
May 16, 2006
Study Start
April 1, 2006
Study Completion
May 1, 2007
Last Updated
March 25, 2009
Record last verified: 2009-03