- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00321490
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder (DIAMOND)
March 24, 2009 updated by: AstraZeneca
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled and Active-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
600
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
- Research Site
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Arizona
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Scottsdale, Arizona, United States
- Research Site
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California
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Beverly Hills, California, United States
- Research Site
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San Diego, California, United States
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Sherman Oaks, California, United States
- Research Site
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Wildomar, California, United States
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Florida
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Boca Raton, Florida, United States
- Research Site
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Bradenton, Florida, United States
- Research Site
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Illinois
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Edwardsville, Illinois, United States
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Louisiana
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Lake Charles, Louisiana, United States
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Maryland
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Baltimore, Maryland, United States
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Massachusetts
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Haverhill, Massachusetts, United States
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Michigan
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Okemos, Michigan, United States
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Minnesota
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St. Paul, Minnesota, United States
- Research Site
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Missouri
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St. Louis, Missouri, United States
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New Jersey
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Princeton, New Jersey, United States
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New Mexico
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Albuquerque, New Mexico, United States
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New York
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New York City, New York, United States
- Research Site
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Ohio
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Dayton, Ohio, United States
- Research Site
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Mayfield Village, Ohio, United States
- Research Site
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Oklahoma
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Oklahoma City, Oklahoma, United States
- Research Site
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Oregon
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Salem, Oregon, United States
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- Research Site
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South Carolina
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Columbia, South Carolina, United States
- Research Site
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Tennessee
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Memphis, Tennessee, United States
- Research Site
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Texas
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Houston, Texas, United States
- Research Site
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Utah
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Salt Lake City, Utah, United States
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Virginia
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Richmond, Virginia, United States
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Washington
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Kirkland, Washington, United States
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West Virginia
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Morgantown, West Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient has a documented clinical diagnosis of Major Depressive Disorder.
- Be able to understand and comply with the requirements of the study.
- Able to understand and provide written informed consent
Exclusion Criteria:
- Patients (female) must not be pregnant or lactating
- Current or past diagnosis of stroke or transient ischemic attack (TIA).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
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Secondary Outcome Measures
Outcome Measure |
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Change from randomization to each assessment in the MADRS total score
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MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Art Lazarus, MD, AstraZeneca
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Int J Neuropsychopharmacol. 2015;18(2). pii: pyu086. doi: 10.1093/ijnp/pyu086. Papakosts, George I [corrected to Papakostas, George I]. Int J Neuropsychopharmacol. 2015 Jul;18(9). pii: pyv056. doi: 10.1093/ijnp/pyv056.
- 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.
- Cutler AJ, Montgomery SA, Feifel D, Lazarus A, Astrom M, Brecher M. Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo- and duloxetine-controlled study. J Clin Psychiatry. 2009 Apr;70(4):526-39. doi: 10.4088/jcp.08m04592. Epub 2009 Apr 7. Erratum In: J Clin Psychiatry. 2009 Dec;70(12):1729.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
May 1, 2006
First Submitted That Met QC Criteria
May 1, 2006
First Posted (Estimate)
May 3, 2006
Study Record Updates
Last Update Posted (Estimate)
March 25, 2009
Last Update Submitted That Met QC Criteria
March 24, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
- Quetiapine Fumarate
Other Study ID Numbers
- D1448C00002
- Diamond
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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