Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder
GOLD
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder
2 other identifiers
interventional
800
1 country
63
Brief Summary
The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2006
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 22, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedMarch 25, 2009
March 1, 2009
May 22, 2006
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from randomization in the HAM-A total score at Day 57
Secondary Outcomes (1)
Change from randomization in CGI-S score at Day 57
Interventions
Eligibility Criteria
You may qualify if:
- Patient has a documented clinical diagnosis of Generalized Anxiety Disorder.
- Be able to understand and comply with the requirements of the study.
- Able to understand and provide written informed consent
You may not qualify if:
- Patients (female) must not be pregnant or lactating
- Current or past diagnosis of stroke or transient ischemic attack (TIA).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (63)
Research Site
Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Burbank, California, United States
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La Mesa, California, United States
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Orange, California, United States
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Pasadena, California, United States
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San Diego, California, United States
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Sherman Oaks, California, United States
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Upland, California, United States
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Wildomar, California, United States
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New Britain, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Bradenton, Florida, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Miami, 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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Edwardsville, Illinois, United States
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Merrillville, Indiana, United States
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Terre Haute, Indiana, United States
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Newton, Kansas, United States
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Prairie Village, Kansas, United States
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Owensboro, Kentucky, United States
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Lake Charles, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Haverhill, Massachusetts, United States
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Okemos, Michigan, United States
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Saint Paul, Minnesota, United States
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St Louis, Missouri, United States
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Kenilworth, New Jersey, United States
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Princeton, New Jersey, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Salem, Oregon, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Richmond, Virginia, United States
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Kirkland, Washington, United States
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Spokane, Washington, United States
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Morgantown, West Virginia, United States
Related Publications (3)
Montgomery SA, Locklear JC, Svedsater H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.
PMID: 24394383DERIVEDStein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6.
PMID: 22143997DERIVEDMerideth C, Cutler AJ, She F, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate monotherapy in the acute treatment of generalized anxiety disorder: a randomized, placebo controlled and active-controlled study. Int Clin Psychopharmacol. 2012 Jan;27(1):40-54. doi: 10.1097/YIC.0b013e32834d9f49.
PMID: 22045039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anders Neijber, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 22, 2006
First Posted
May 24, 2006
Study Start
April 1, 2006
Study Completion
September 1, 2007
Last Updated
March 25, 2009
Record last verified: 2009-03