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Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder (DIAMOND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00321490
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Quetiapine fumarate Drug: Duloxetine Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures :
  1. Change from randomization to each assessment in the MADRS total score
  2. MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321490


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, Arizona
Research Site
Scottsdale, Arizona, United States
United States, California
Research Site
Beverly Hills, California, United States
Research Site
San Diego, California, United States
Research Site
Sherman Oaks, California, United States
Research Site
Wildomar, California, United States
United States, Florida
Research Site
Boca Raton, Florida, United States
Research Site
Bradenton, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
West Palm Beach, Florida, United States
United States, Illinois
Research Site
Edwardsville, Illinois, United States
United States, Louisiana
Research Site
Lake Charles, Louisiana, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Massachusetts
Research Site
Haverhill, Massachusetts, United States
United States, Michigan
Research Site
Okemos, Michigan, United States
United States, Minnesota
Research Site
St. Paul, Minnesota, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, New Jersey
Research Site
Princeton, New Jersey, United States
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States
United States, New York
Research Site
New York City, New York, United States
United States, Ohio
Research Site
Dayton, Ohio, United States
Research Site
Mayfield Village, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Oregon
Research Site
Salem, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, South Carolina
Research Site
Columbia, South Carolina, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
United States, Texas
Research Site
Houston, Texas, United States
United States, Utah
Research Site
Salt Lake City, Utah, United States
United States, Virginia
Research Site
Richmond, Virginia, United States
United States, Washington
Research Site
Kirkland, Washington, United States
United States, West Virginia
Research Site
Morgantown, West Virginia, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Art Lazarus, MD AstraZeneca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00321490    
Other Study ID Numbers: D1448C00002
Diamond
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
MDD
Quetiapine fumarate, sustained release
Depression
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Dopamine Agents