Major Depressive Disorder Clinical Trial
— AMETHYSTOfficial title:
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
| Verified date | March 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 3000 |
| Est. completion date | August 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Research Site | Vratza | |
| Canada | Research Site | Burlington | Ontario |
| Canada | Research Site | Gatineau | Quebec |
| Canada | Research Site | Miramichi | New Brunswick |
| Canada | Research Site | Mississauga | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Sherbrooke | Quebec |
| Canada | Research Site | Vancouver | British Columbia |
| Canada | Research Site | Victoria | British Columbia |
| Puerto Rico | Research Site | Rio Predia | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Iasi | |
| Romania | Research Site | Pitesti | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | St Petersburg | |
| Slovakia | Research Site | Piestany | |
| Slovakia | Research Site | Presov | |
| Slovakia | Research Site | Sered | |
| Slovakia | Research Site | Trencin | |
| United Kingdom | Research Site | Ayrshire | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Reading | |
| United States | Research Site | Allentown | Pennsylvania |
| United States | Research Site | Altamonte Springs | Florida |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Augusta | Georgia |
| United States | Research Site | Avon Lake | Ohio |
| United States | Research Site | Bala Cynwyd | Pennsylvania |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Bloomfield Hills | Michigan |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Brooklyn | New York |
| United States | Research Site | Cambridge | Massachusetts |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Cedarhurst | New York |
| United States | Research Site | Cerritos | California |
| United States | Research Site | Chagrin Falls | Ohio |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Charlottesville | Virginia |
| United States | Research Site | Cherry Hill | New Jersey |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Clinton Twp | Michigan |
| United States | Research Site | Coatesville | Pennsylvania |
| United States | Research Site | Coeur D'Alene | Idaho |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Coral Springs | Florida |
| United States | Research Site | Costa Mesa | California |
| United States | Research Site | Cromwell | Connecticut |
| United States | Research Site | Decatur | Georgia |
| United States | Research Site | DeLand | Florida |
| United States | Research Site | Desoto | Texas |
| United States | Research Site | El Centro | California |
| United States | Research Site | Eugene | Oregon |
| United States | Research Site | Fall River | Massachusetts |
| United States | Research Site | Farmington | Connecticut |
| United States | Research Site | Farmington Hills | Michigan |
| United States | Research Site | Flowood | Mississippi |
| United States | Research Site | Fresno | California |
| United States | Research Site | Friendswood | Texas |
| United States | Research Site | Ft Myers | Florida |
| United States | Research Site | Gainsville | Florida |
| United States | Research Site | Glen Burnie | Maryland |
| United States | Research Site | Granite City | Illinois |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Greer | South Carolina |
| United States | Research Site | Havertown | Pennsylvania |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Hoffman Estates | Illinois |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jenkintown | Pennsylvania |
| United States | Research Site | Kenilworth | New Jersey |
| United States | Research Site | La Mesa | California |
| United States | Research Site | Lafayette | Indiana |
| United States | Research Site | Lake Jackson | Texas |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Libertyville | Illinois |
| United States | Research Site | Lincoln | Rhode Island |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Media | Pennsylvania |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Mesa | Arizona |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Middleburg Heights | Ohio |
| United States | Research Site | Middletown | Connecticut |
| United States | Research Site | Midlothian | Virginia |
| United States | Research Site | Midvale | Utah |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Moon Township | Pennsylvania |
| United States | Research Site | Mount Kisco | New York |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Port Richey | Florida |
| United States | Research Site | New York | New York |
| United States | Research Site | North Miami | Florida |
| United States | Research Site | Northfield | Illinois |
| United States | Research Site | Ocala | Florida |
| United States | Research Site | Oceanside | California |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Olean | New York |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Owensboro | Kentucky |
| United States | Research Site | Palm Beach Gardens | Florida |
| United States | Research Site | Pasadena | California |
| United States | Research Site | Peoria | Arizona |
| United States | Research Site | Pico Rivera | California |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Pittsfield | Massachusetts |
| United States | Research Site | Portage | Michigan |
| United States | Research Site | Prairie Village | Kansas |
| United States | Research Site | Princeton | New Jersey |
| United States | Research Site | Providence | Rhode Island |
| United States | Research Site | Pueblo | Colorado |
| United States | Research Site | Reading | Pennsylvania |
| United States | Research Site | Redlands | California |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Ridgeland | Mississippi |
| United States | Research Site | Riverside | California |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Rochester Hills | Michigan |
| United States | Research Site | Rockville | Maryland |
| United States | Research Site | Roswell | Georgia |
| United States | Research Site | Salem | Oregon |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Sandy Springs | Georgia |
| United States | Research Site | Santa Ana | California |
| United States | Research Site | Sarasota | Florida |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Sioux Falls | South Dakota |
| United States | Research Site | Skokie | Illinois |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Springfield | Massachusetts |
| United States | Research Site | St Peters | Missouri |
| United States | Research Site | St. Charles | Missouri |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | St. Petersberg | Florida |
| United States | Research Site | Stanford | California |
| United States | Research Site | Stuart | Florida |
| United States | Research Site | Terre Haute | Indiana |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Toms River | New Jersey |
| United States | Research Site | Topeka | Kansas |
| United States | Research Site | Torrance | California |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Tuscaloosa | Alabama |
| United States | Research Site | Upland | California |
| United States | Research Site | Valparaiso | Indiana |
| United States | Research Site | Virginia Beach | Virginia |
| United States | Research Site | Vista | California |
| United States | Research Site | W Palm Beach | Florida |
| United States | Research Site | Walnut Creek | California |
| United States | Research Site | Washington | District of Columbia |
| United States | Research Site | Wichita Falls | Texas |
| United States | Research Site | Wilmington | Delaware |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Woodstock | Vermont |
| United States | Research Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Bulgaria, Canada, Puerto Rico, Romania, Russian Federation, Slovakia, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Evaluate quetiapine SR compared to placebo on health related quality of life. |
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