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Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder (MOONSTONE)

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: NCT00320268
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 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 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): NCT00320268


Locations
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United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, California
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
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Connecticut
Research Site
Norwich, Connecticut, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
Jacksonville, Florida, United States
Research Site
Winter Park, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
Research Site
Smyrna, Georgia, United States
United States, Idaho
Research Site
Eagle, Idaho, United States
United States, Illinois
Research Site
Oak Brook, Illinois, United States
United States, Kansas
Research Site
Wichita, Kansas, United States
United States, Louisiana
Research Site
Shreveport, Louisiana, United States
United States, Michigan
Research Site
Farmington Hills, Michigan, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, Nevada
Research Site
Las Vegas, Nevada, United States
United States, New Jersey
Research Site
Cherry Hill, New Jersey, United States
Research Site
Clementon, New Jersey, United States
United States, New York
Research Site
Brooklyn, New York, United States
Research Site
New York City, New York, United States
Research Site
Staten Island, New York, United States
United States, North Carolina
Research Site
Raleigh, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oklahoma
Research Site
Tulsa, Oklahoma, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Norristown, Pennsylvania, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
United States, Texas
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
United States, Washington
Research Site
Bellevue, Washington, United States
Research Site
Seattle, Washington, United States
United States, West Virginia
Research Site
Charleston, West Virginia, United States
United States, Wisconsin
Research Site
Brown Deer, Wisconsin, 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: NCT00320268    
Other Study ID Numbers: D1448C00001
Moonstone
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
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs