Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder (AMETHYST)

A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR™) As Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder

The purpose of this study is to determine safety & efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo & to evaluate quality of sleep, overall quality of life, and effect, if any, on anxiety and satisfaction PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Quetiapine Fumarate Sustained Release

• Study Type: Interventional
• Enrollment: 3000
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Vratza, Bulgaria
    • Research Site
• Canada
  • Quebec, Canada
    • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Research Site
    • Victoria, British Columbia, Canada
      • Research Site
  • New Brunswick
    • Miramichi, New Brunswick, Canada
      • Research Site
  • Ontario
    • Burlington, Ontario, Canada
      • Research Site
    • Mississauga, Ontario, Canada
      • Research Site
    • Ottawa, Ontario, Canada
      • Research Site
  • Quebec
    • Gatineau, Quebec, Canada
      • Research Site
    • Montreal, Quebec, Canada
      • Research Site
    • Sherbrooke, Quebec, Canada
      • Research Site
• Puerto Rico
  • Rio Predia, Puerto Rico
    • Research Site
• Romania
  • Bucharest, Romania
    • Research Site
  • Iasi, Romania
    • Research Site
  • Pitesti, Romania
    • Research Site
• Russian Federation
  • Moscow, Russian Federation
    • Research Site
  • St Petersburg, Russian Federation
    • Research Site
• Slovakia
  • Piestany, Slovakia
    • Research Site
  • Presov, Slovakia
    • Research Site
  • Sered, Slovakia
    • Research Site
  • Trencin, Slovakia
    • Research Site
• United Kingdom
  • Ayrshire, United Kingdom
    • Research Site
  • Glasgow, United Kingdom
    • Research Site
  • Reading, United Kingdom
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Research Site
    • Tuscaloosa, Alabama, United States
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  • Arizona
    • Mesa, Arizona, United States
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    • Peoria, Arizona, United States
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  • Arkansas
    • Little Rock, Arkansas, United States
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  • California
    • Anaheim, California, United States
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    • Cerritos, California, United States
      • Research Site
    • Costa Mesa, California, United States
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    • El Centro, California, United States
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    • Fresno, California, United States
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    • La Mesa, California, United States
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    • Los Angeles, California, United States
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    • Oceanside, California, United States
      • Research Site
    • Pasadena, California, United States
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    • Pico Rivera, California, United States
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    • Redlands, California, United States
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    • Riverside, California, United States
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    • San Diego, California, United States
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    • Santa Ana, California, United States
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    • Stanford, California, United States
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    • Torrance, California, United States
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    • Upland, California, United States
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    • Vista, California, United States
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    • Walnut Creek, California, United States
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  • Colorado
    • Colorado Springs, Colorado, United States
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    • Pueblo, Colorado, United States
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  • Connecticut
    • Cromwell, Connecticut, United States
      • Research Site
    • Farmington, Connecticut, United States
      • Research Site
    • Middletown, Connecticut, United States
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  • Delaware
    • Wilmington, Delaware, United States
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  • District of Columbia
    • Washington, District of Columbia, United States
      • Research Site
  • Florida
    • Altamonte Springs, Florida, United States
      • Research Site
    • Clearwater, Florida, United States
      • Research Site
    • Coral Springs, Florida, United States
      • Research Site
    • DeLand, Florida, United States
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    • Ft Myers, Florida, United States
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    • Gainsville, Florida, United States
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    • Hialeah, Florida, United States
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    • Jacksonville, Florida, United States
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    • Miami, Florida, United States
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    • New Port Richey, Florida, United States
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    • North Miami, Florida, United States
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    • Ocala, Florida, United States
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    • Orlando, Florida, United States
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    • Palm Beach Gardens, Florida, United States
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    • Sarasota, Florida, United States
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    • St. Petersberg, Florida, United States
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    • Stuart, Florida, United States
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    • W Palm Beach, Florida, United States
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  • Georgia
    • Atlanta, Georgia, United States
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    • Augusta, Georgia, United States
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    • Columbus, Georgia, United States
      • Research Site
    • Decatur, Georgia, United States
      • Research Site
    • Roswell, Georgia, United States
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    • Sandy Springs, Georgia, United States
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  • Idaho
    • Coeur D'Alene, Idaho, United States
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  • Illinois
    • Chicago, Illinois, United States
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    • Granite City, Illinois, United States
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    • Hoffman Estates, Illinois, United States
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    • Libertyville, Illinois, United States
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    • Northfield, Illinois, United States
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    • Skokie, Illinois, United States
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  • Indiana
    • Lafayette, Indiana, United States
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    • Terre Haute, Indiana, United States
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    • Valparaiso, Indiana, United States
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  • Kansas
    • Prairie Village, Kansas, United States
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    • Topeka, Kansas, United States
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  • Kentucky
    • Owensboro, Kentucky, United States
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  • Louisiana
    • Shreveport, Louisiana, United States
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States
      • Research Site
    • Glen Burnie, Maryland, United States
      • Research Site
    • Rockville, Maryland, United States
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  • Massachusetts
    • Boston, Massachusetts, United States
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    • Cambridge, Massachusetts, United States
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    • Fall River, Massachusetts, United States
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    • Pittsfield, Massachusetts, United States
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    • Springfield, Massachusetts, United States
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    • Worcester, Massachusetts, United States
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  • Michigan
    • Bloomfield Hills, Michigan, United States
      • Research Site
    • Clinton Twp, Michigan, United States
      • Research Site
    • Farmington Hills, Michigan, United States
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    • Portage, Michigan, United States
      • Research Site
    • Rochester Hills, Michigan, United States
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Research Site
  • Mississippi
    • Flowood, Mississippi, United States
      • Research Site
    • Ridgeland, Mississippi, United States
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  • Missouri
    • St Peters, Missouri, United States
      • Research Site
    • St. Charles, Missouri, United States
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    • St. Louis, Missouri, United States
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  • Nevada
    • Las Vegas, Nevada, United States
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  • New Jersey
    • Cherry Hill, New Jersey, United States
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    • Kenilworth, New Jersey, United States
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    • Princeton, New Jersey, United States
      • Research Site
    • Toms River, New Jersey, United States
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  • New York
    • Brooklyn, New York, United States
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    • Cedarhurst, New York, United States
      • Research Site
    • Mount Kisco, New York, United States
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    • New York, New York, United States
      • Research Site
    • Olean, New York, United States
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    • Rochester, New York, United States
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  • North Carolina
    • Charlotte, North Carolina, United States
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    • Greensboro, North Carolina, United States
      • Research Site
    • Winston-Salem, North Carolina, United States
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  • Ohio
    • Avon Lake, Ohio, United States
      • Research Site
    • Canton, Ohio, United States
      • Research Site
    • Chagrin Falls, Ohio, United States
      • Research Site
    • Cincinnati, Ohio, United States
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    • Cleveland, Ohio, United States
      • Research Site
    • Middleburg Heights, Ohio, United States
      • Research Site
    • Toledo, Ohio, United States
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
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    • Tulsa, Oklahoma, United States
      • Research Site
  • Oregon
    • Eugene, Oregon, United States
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    • Salem, Oregon, United States
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  • Pennsylvania
    • Allentown, Pennsylvania, United States
      • Research Site
    • Bala Cynwyd, Pennsylvania, United States
      • Research Site
    • Coatesville, Pennsylvania, United States
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    • Havertown, Pennsylvania, United States
      • Research Site
    • Jenkintown, Pennsylvania, United States
      • Research Site
    • Media, Pennsylvania, United States
      • Research Site
    • Moon Township, Pennsylvania, United States
      • Research Site
    • Pittsburgh, Pennsylvania, United States
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    • Reading, Pennsylvania, United States
      • Research Site
  • Rhode Island
    • Lincoln, Rhode Island, United States
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    • Providence, Rhode Island, United States
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States
      • Research Site
    • Greer, South Carolina, United States
      • Research Site
  • South Dakota
    • Sioux Falls, South Dakota, United States
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States
      • Research Site
    • Nashville, Tennessee, United States
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  • Texas
    • Desoto, Texas, United States
      • Research Site
    • Friendswood, Texas, United States
      • Research Site
    • Houston, Texas, United States
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    • Lake Jackson, Texas, United States
      • Research Site
    • San Antonio, Texas, United States
      • Research Site
    • Wichita Falls, Texas, United States
      • Research Site
  • Utah
    • Midvale, Utah, United States
      • Research Site
  • Vermont
    • Woodstock, Vermont, United States
      • Research Site
  • Virginia
    • Charlottesville, Virginia, United States
      • Research Site
    • Midlothian, Virginia, United States
      • Research Site
    • Richmond, Virginia, United States
      • Research Site
    • Virginia Beach, Virginia, United States
      • Research Site
  • Washington
    • Spokane, Washington, United States
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • Research Site

Participation Criteria

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:

• Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major Depressive Disorder,
• Single Episode, or 296.3x Major Depressive Disorder,

Exclusion Criteria:

• Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment,
• Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patients current psychiatric status.
• Patients whose current episode of depression>12 months or <4 weeks from enrollment

Study Plan

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
To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)

Secondary Outcome Measures

Outcome Measure
Evaluate quetiapine SR compared to placebo on health related quality of life.

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: January 17, 2006
• First Submitted That Met QC Criteria: January 17, 2006
• First Posted (Estimate): January 19, 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

• Keywords: Major Depressive Disorder; Seroquel SR™
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: D1448C00005; Amethyst