Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in Combination With an Antidepressant in the Treatment of Major Depressive Disorders
NCT ID: NCT00326105
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
450 participants
INTERVENTIONAL
2006-04-30
2007-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders
NCT00326144
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
NCT00351910
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder
NCT00320268
Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder
NCT00278941
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
NCT00351169
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Quetiapine fumarate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Seroquel Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Phoenix, Arizona, United States
Research Site
El Centro, California, United States
Research Site
Irvine, California, United States
Research Site
Oceanside, California, United States
Research Site
San Diego, California, United States
Research Site
Pueblo, Colorado, United States
Research Site
Coral Springs, Florida, United States
Research Site
DeLand, Florida, United States
Research Site
Gainsville, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Roswell, Georgia, United States
Research Site
Hoffman Estates, Illinois, United States
Research Site
Naperville, Illinois, United States
Research Site
Oak Brook, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Lafayette, Indiana, United States
Research Site
Valparaiso, Indiana, United States
Research Site
Prairie Village, Kansas, United States
Research Site
Wichita, Kansas, United States
Research Site
Shreveport, Louisiana, United States
Research SIte
Glen Burnie, Maryland, United States
Research Site
Braintree, Massachusetts, United States
Research Site
Springfield, Massachusetts, United States
Research Site
Clinton Township, Michigan, United States
Research Site
Kalamazoo, Michigan, United States
Research Site
Royal Oak, Michigan, United States
Research Site
Saint Charles, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Cherry Hill, New Jersey, United States
Research Site
Clementon, New Jersey, United States
Research Site
Cedarhurst, New York, United States
Research Site
New York, New York, United States
Research Site
Olean, New York, United States
Research Site
Rochester, New York, United States
Research Site
Staten Island, New York, United States
Research Site
Beechwood, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Norman, Oklahoma, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Lincoln, Rhode Island, United States
Research Site
Columbia, South Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Friendswood, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research SIte
Wichita Falls, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Arlington, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Bellevue, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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, 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.
Bauer 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.
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.
Bauer 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.
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.
El-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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PEARL
Identifier Type: -
Identifier Source: secondary_id
D1448C00006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.