Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.
PLATINUM
A Multi-Centre,Double-Blind,Randomised-Withdrawal,Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period
2 other identifiers
interventional
575
11 countries
114
Brief Summary
The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder (GAD). 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 Mar 2006
114 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
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 11, 2006
CompletedFirst Posted
Study publicly available on registry
April 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMarch 25, 2009
March 1, 2009
April 11, 2006
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from randomisation to occurrence of an anxiety event
Secondary Outcomes (5)
Occurrence of an anxiety event
Change from randomisation in HAM-A/CGI-S scores
In HAM-A psychic/somatic anxiety factor scores
In MADRS total score and in MADRS item 10 score (suicidal thought)
Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS
Interventions
Eligibility Criteria
You may qualify if:
- Patients will be male or female, 18 to 65 years of age (inclusive), with a diagnosis of GAD according to DSM-IV criteria 300.02 as assessed by the MINI.
You may not qualify if:
- Patients suffering from depressive symptoms, defined as having a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 17 or more at the enrolment visit, will be excluded from participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (114)
Research Site
Mesa, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Fresno, California, United States
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La Mesa, California, United States
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Oceanside, California, United States
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Redlands, California, United States
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Coral Springs, Florida, United States
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DeLand, Florida, United States
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Fort 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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North Miami, Florida, United States
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Orlando, Florida, United States
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Saint Petersberg, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Marietta, Georgia, United States
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Roswell, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Hoffman Estates, Illinois, United States
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Libertyville, Illinois, United States
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Valparaiso, Indiana, United States
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Prairie Village, Kansas, United States
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Owensboro, Kentucky, United States
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Paducah, Kentucky, United States
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Shreveport, Louisiana, United States
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Glen Burnie, Maryland, United States
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Boston, Massachusetts, United States
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Cambridge, Massachusetts, United States
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Pittsfield, Massachusetts, United States
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Saint Charles, Missouri, United States
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Piscataway, New Jersey, United States
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Cedarhurst, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Avon Lake, Ohio, United States
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Beechwood, Ohio, United States
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Cincinnati, Ohio, United States
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Middleburg Heights, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Allentown, Pennsylvania, United States
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Havertown, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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North Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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DeSoto, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Midvale, Utah, United States
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Richmond, Virginia, United States
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Brisbane, Queensland, Australia
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Everton Park, Queensland, Australia
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West Burleigh, Queensland, Australia
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Malvern, Victoria, Australia
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Prahran, Victoria, Australia
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Edmonton, Alberta, Canada
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Bathurst, New Brunswick, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Orléans, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Gatineau, Quebec, Canada
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Montreal, Quebec, Canada
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Helsinki, Finland
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Joensuu, Finland
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Kuopio, Finland
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Oulu, Finland
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Pori, Finland
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Seinäjoki, Finland
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Turku, Finland
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Berlin, Germany
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Göttingen, Germany
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Jena, Germany
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Leipzig, Germany
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München, Germany
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Naumburg, Germany
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Nuremberg, Germany
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Schwerin, Germany
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Siegen, Germany
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Balassagyarmat, Hungary
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Budapest, Hungary
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Győr, Hungary
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Gyula, Hungary
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Kecskemét, Hungary
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Nyíregyháza, Hungary
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Bandung, West Java, Indonesia
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Jakarta, Indonesia
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Cebu City, Philippines
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Davao City, Philippines
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Mandaluyong, Philippines
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Manila, Philippines
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Quezon City, Philippines
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Moscow, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Seoul, South Korea
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Reading, Berkshire, United Kingdom
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Crawley, West Sussex, United Kingdom
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Blackpool, United Kingdom
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Bolton, United Kingdom
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Cardiff, United Kingdom
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Chorley, United Kingdom
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Coventry, United Kingdom
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Glasgow, United Kingdom
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Hamilton, United Kingdom
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Liverpool, United Kingdom
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Manchester, United Kingdom
Related Publications (1)
Sheehan DV, Svedsater H, Locklear JC, Eriksson H. Effects of extended-release quetiapine fumarate on long-term functioning and sleep quality in patients with Generalized Anxiety Disorder (GAD): data from a randomized-withdrawal, placebo-controlled maintenance study. J Affect Disord. 2013 Dec;151(3):906-13. doi: 10.1016/j.jad.2013.07.037. Epub 2013 Aug 16.
PMID: 24135509DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martin Brecher, 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
April 11, 2006
First Posted
April 13, 2006
Study Start
March 1, 2006
Study Completion
August 1, 2007
Last Updated
March 25, 2009
Record last verified: 2009-03