Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in Combination With an Antidepressant in the Treatment of Major Depressive Disorders
PEARL
A Multicenter, Double-Blind, Randomized, 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 (PEARL STUDY)
2 other identifiers
interventional
450
1 country
56
Brief Summary
The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in patients with MDD with inadequate response to an antidepressant treatment. 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 Apr 2006
Shorter than P25 for phase_3 major-depressive-disorder
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
July 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 in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS
Secondary Outcomes (2)
To evaluate if quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone
To evaluate if quetiapine SR in combination with an antidepressant reduces anxiety symptoms in patients with MDD, compared to an antidepressant alone
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 (56)
Research Site
Phoenix, Arizona, United States
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El Centro, California, United States
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Irvine, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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Pueblo, Colorado, United States
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Coral Springs, Florida, United States
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DeLand, Florida, United States
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Gainsville, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Roswell, Georgia, United States
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Hoffman Estates, Illinois, United States
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Naperville, Illinois, United States
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Oak Brook, Illinois, United States
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Valparaiso, Indiana, United States
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Prairie Village, Kansas, United States
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Wichita, Kansas, United States
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Shreveport, Louisiana, United States
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Glen Burnie, Maryland, United States
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Braintree, Massachusetts, United States
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Springfield, Massachusetts, United States
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Clinton Township, Michigan, United States
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Kalamazoo, Michigan, United States
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Royal Oak, Michigan, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Cherry Hill, New Jersey, United States
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Clementon, New Jersey, United States
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Cedarhurst, New York, United States
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New York, New York, United States
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Olean, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Beechwood, Ohio, United States
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Toledo, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Lincoln, Rhode Island, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Friendswood, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Salt Lake City, Utah, United States
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Arlington, Virginia, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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: 23497790DERIVEDEl-Khalili N, Joyce M, Atkinson S, Buynak RJ, Datto C, Lindgren P, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant treatment: a multicentre, randomized, double-blind, placebo-controlled study. Int J Neuropsychopharmacol. 2010 Aug;13(7):917-32. doi: 10.1017/S1461145710000015. Epub 2010 Feb 23.
PMID: 20175941DERIVED
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
- 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
July 1, 2007
Last Updated
March 25, 2009
Record last verified: 2009-03