- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00329446
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder (GOLD)
March 24, 2009 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
800
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
- Research Site
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Arizona
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Scottsdale, Arizona, United States
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Arkansas
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Little Rock, Arkansas, United States
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California
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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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Connecticut
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New Britain, Connecticut, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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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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Ft 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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Illinois
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Edwardsville, Illinois, United States
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Indiana
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Merrillville, Indiana, United States
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Terre Haute, Indiana, United States
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Kansas
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Newton, Kansas, United States
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Prairie Village, Kansas, United States
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Kentucky
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Owensboro, Kentucky, United States
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Louisiana
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Lake Charles, Louisiana, United States
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Maryland
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Baltimore, Maryland, United States
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Massachusetts
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Boston, Massachusetts, United States
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Haverhill, Massachusetts, United States
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Michigan
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Okemos, Michigan, United States
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Minnesota
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St. Paul, Minnesota, United States
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Missouri
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St. Louis, Missouri, United States
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New Jersey
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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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New Mexico
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Albuquerque, New Mexico, United States
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New York
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New York City, New York, United States
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North Carolina
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Chapel Hill, North Carolina, United States
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Ohio
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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
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Oklahoma City, Oklahoma, United States
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Oregon
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Eugene, Oregon, United States
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Salem, Oregon, United States
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Pennsylvania
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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South Carolina
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Columbia, South Carolina, United States
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Tennessee
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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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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Utah
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Salt Lake City, Utah, United States
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Virginia
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Richmond, Virginia, United States
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Washington
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Kirkland, Washington, United States
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Spokane, Washington, United States
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West Virginia
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Morgantown, West Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
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Change from randomization in the HAM-A total score at Day 57
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Secondary Outcome Measures
Outcome Measure |
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Change from randomization in CGI-S score at Day 57
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Anders Neijber, MD, AstraZeneca
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
May 22, 2006
First Submitted That Met QC Criteria
May 22, 2006
First Posted (Estimate)
May 24, 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
Additional Relevant MeSH Terms
- Mental Disorders
- Anxiety Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
- Quetiapine Fumarate
Other Study ID Numbers
- D1448C00010
- GOLD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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