Back to resultsSafety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder (GOLD)
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Quetiapine Fumarate
Escitalopram oxylate
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring GAD, anxiety
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients (female) must not be pregnant or lactating Current or past diagnosis of stroke or transient ischemic attack (TIA).
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Outcomes
Primary Outcome Measures
Change from randomization in the HAM-A total score at Day 57
Secondary Outcome Measures
Change from randomization in CGI-S score at Day 57
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00329446
Brief Title
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder
Acronym
GOLD
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
GAD, anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate
Intervention Type
Drug
Intervention Name(s)
Escitalopram oxylate
Primary Outcome Measure Information:
Title
Change from randomization in the HAM-A total score at Day 57
Secondary Outcome Measure Information:
Title
Change from randomization in CGI-S score at Day 57
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients (female) must not be pregnant or lactating
Current or past diagnosis of stroke or transient ischemic attack (TIA).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Neijber, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
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United States
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Scottsdale
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Arizona
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United States
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Little Rock
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Arkansas
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United States
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Beverly Hills
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California
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United States
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Burbank
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California
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United States
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La Mesa
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California
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United States
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Orange
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California
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United States
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Pasadena
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California
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United States
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San Diego
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California
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United States
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Sherman Oaks
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California
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United States
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Upland
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California
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United States
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Wildomar
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California
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United States
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New Britain
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Connecticut
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United States
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Washington
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District of Columbia
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United States
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Boca Raton
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Florida
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United States
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Bradenton
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Florida
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United States
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Deland
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Florida
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United States
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Fort Lauderdale
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Florida
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United States
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Ft Myers
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United States
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Jacksonville
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Florida
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United States
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Maitland
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Florida
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United States
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Miami
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United States
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Orlando
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Florida
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United States
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Tampa
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United States
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West Palm Beach
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United States
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Edwardsville
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Illinois
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United States
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Merrillville
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Indiana
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United States
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Terre Haute
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Indiana
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United States
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Newton
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Kansas
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United States
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Prairie Village
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Kansas
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United States
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Owensboro
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Kentucky
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United States
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Lake Charles
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Louisiana
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United States
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Baltimore
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Maryland
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United States
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Boston
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Massachusetts
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United States
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Haverhill
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Massachusetts
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United States
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Okemos
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Michigan
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United States
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St. Paul
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Minnesota
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St. Louis
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Missouri
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United States
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Kenilworth
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New Jersey
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United States
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Princeton
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New Jersey
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United States
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Toms River
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New Jersey
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United States
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Albuquerque
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New Mexico
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United States
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New York City
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New York
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United States
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Chapel Hill
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North Carolina
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United States
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Cleveland
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Ohio
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United States
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Dayton
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Ohio
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United States
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Toledo
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Ohio
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United States
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Oklahoma City
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Oklahoma
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United States
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Eugene
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Oregon
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United States
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Salem
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Oregon
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United States
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Allentown
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Pennsylvania
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United States
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Philadelphia
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Pennsylvania
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United States
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Columbia
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South Carolina
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United States
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Memphis
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Tennessee
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United States
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Nashville
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Tennessee
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United States
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Dallas
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Texas
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United States
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Houston
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Texas
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San Antonio
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Texas
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United States
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Salt Lake City
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Utah
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United States
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Richmond
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Virginia
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United States
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Kirkland
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Washington
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United States
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Spokane
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Washington
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United States
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Morgantown
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West Virginia
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United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24394383
Citation
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.
Results Reference
derived
PubMed Identifier
22143997
Citation
Stein 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.
Results Reference
derived
PubMed Identifier
22045039
Citation
Merideth 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.
Results Reference
derived
Learn more about this trial
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder
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