Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder
NCT ID: NCT00320268
Last Updated: 2009-03-25
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
600 participants
INTERVENTIONAL
2006-04-30
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Quetiapine fumarate
Eligibility Criteria
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Inclusion Criteria
* Be able to understand and comply with the requirements of the study.
* Able to understand and provide written informed consent
Exclusion Criteria
* Current or past diagnosis of stroke or transient ischemic attack (TIA).
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Art Lazarus, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Little Rock, Arkansas, United States
Research Site
Newport Beach, California, United States
Research Site
Northridge, California, United States
Research Site
Oceanside, California, United States
Research Site
Santa Ana, California, United States
Research Site
Denver, Colorado, United States
Research Site
Norwich, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Jacksonville, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Smyrna, Georgia, United States
Research Site
Eagle, Idaho, United States
Research Site
Oak Brook, Illinois, United States
Research Site
Wichita, Kansas, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Cherry Hill, New Jersey, United States
Research Site
Clementon, New Jersey, United States
Research Site
Brooklyn, New York, United States
Research Site
New York, New York, United States
Research Site
Staten Island, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Tulsa, Oklahoma, United States
Research Site
Portland, Oregon, United States
Research Site
Norristown, Pennsylvania, United States
Research Site
Memphis, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Bellevue, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Charleston, West Virginia, United States
Research Site
Brown Deer, Wisconsin, United States
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.
Vieta 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.
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.
Weisler RH, Montgomery SA, Earley WR, Szamosi J, Lazarus A. Efficacy of extended release quetiapine fumarate monotherapy in patients with major depressive disorder: a pooled analysis of two 6-week, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2012 Jan;27(1):27-39. doi: 10.1097/YIC.0b013e32834d6f91.
Weisler R, Joyce M, McGill L, Lazarus A, Szamosi J, Eriksson H; Moonstone Study Group. Extended release quetiapine fumarate monotherapy for major depressive disorder: results of a double-blind, randomized, placebo-controlled study. CNS Spectr. 2009 Jun;14(6):299-313. doi: 10.1017/s1092852900020307.
Other Identifiers
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Moonstone
Identifier Type: -
Identifier Source: secondary_id
D1448C00001
Identifier Type: -
Identifier Source: org_study_id
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