Back to resultsSafety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients. (PLATINUM)
Primary Purpose
Anxiety Disorders
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quetiapine SR
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring Generalised Anxiety Disorder
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
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Outcomes
Primary Outcome Measures
Time from randomisation to occurrence of an anxiety event
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00314210
Brief Title
Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.
Acronym
PLATINUM
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Generalised Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
575 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine SR
Primary Outcome Measure Information:
Title
Time from randomisation to occurrence of an anxiety event
Secondary Outcome Measure Information:
Title
Occurrence of an anxiety event
Title
Change from randomisation in HAM-A/CGI-S scores
Title
In HAM-A psychic/somatic anxiety factor scores
Title
In MADRS total score and in MADRS item 10 score (suicidal thought)
Title
Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS
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:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Brecher, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Research Site
City
Mesa
State/Province
Arizona
Country
United States
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Peoria
State/Province
Arizona
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United States
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Phoenix
State/Province
Arizona
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United States
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Fresno
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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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Oceanside
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California
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United States
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Redlands
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California
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United States
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Coral Springs
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Florida
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United States
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Deland
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United States
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Ft Myers
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Florida
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United States
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Gainsville
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Florida
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United States
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Hialeah
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Florida
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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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North Miami
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Florida
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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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St Petersberg
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Florida
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United States
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Atlanta
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Georgia
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United States
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Columbus
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Georgia
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United States
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Marietta
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Georgia
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United States
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Roswell
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Georgia
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United States
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Coeur D'alene
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Idaho
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United States
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Hoffman Estates
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Illinois
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United States
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Libertyville
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Illinois
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United States
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Indianapolis
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United States
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Lafayette
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Indiana
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United States
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Valparaiso
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Indiana
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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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Paducah
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Kentucky
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United States
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Shreveport
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Louisiana
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United States
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Glen Burnie
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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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Cambridge
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Massachusetts
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United States
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Pittsfield
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Massachusetts
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United States
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St Charles
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Missouri
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United States
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Piscataway
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New Jersey
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United States
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Bronx
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New York
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United States
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Cedarhurst
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New York
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United States
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New York
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New York
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United States
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Rochester
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United States
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Avon Lake
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United States
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Beechwood
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United States
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Cincinnati
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United States
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Middleburg Heights
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United States
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Toledo
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Oklahoma City
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Allentown
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Havertown
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United States
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Memphis
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United States
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Desoto
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United States
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San Antonio
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United States
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Wichita Falls
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Midvale
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Richmond
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United States
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Brisbane
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Australia
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Everton Park
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Australia
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West Burleigh
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Queensland
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Australia
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Malvern
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Victoria
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Australia
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Prahran
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Victoria
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Australia
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Edmonton
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Canada
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Bathurst
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Canada
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Kingston
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Canada
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Orleans
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Canada
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Toronto
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Canada
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Waterloo
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Canada
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Gatineau
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Canada
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Montreal
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Quebec
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Canada
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Helsinki
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Finland
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Joensuu
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Finland
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Kuopio
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Finland
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Oulu
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Finland
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Pori
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Finland
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Seinajoki
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Finland
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Turku
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Finland
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Berlin
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Germany
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Gottingen
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Germany
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Jena
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Germany
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Leipzig
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Germany
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München
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Germany
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Naumburg
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Germany
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Nurnberg
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Germany
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Schwerin
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Germany
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Siegen
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Germany
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Balassagyarmat
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Hungary
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Budapest
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Hungary
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Gyor
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Hungary
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Gyula
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Hungary
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Kecskemét
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Hungary
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Nyíregyháza
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Hungary
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Bandung
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West Java
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Indonesia
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Jakarta
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Indonesia
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Seoul
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Korea, Republic of
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Cebu City
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Philippines
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Davao City
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Philippines
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Mandaluyong City
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Philippines
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Manila
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Philippines
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Quezon City
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Philippines
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Moscow
Country
Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Russian Federation
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Reading
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Berkshire
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United Kingdom
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Crawley
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West Sussex
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United Kingdom
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Blackpool
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United Kingdom
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Bolton
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United Kingdom
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Cardiff
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United Kingdom
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Chorley
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United Kingdom
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Coventry
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United Kingdom
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Glasgow
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United Kingdom
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Hamilton
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United Kingdom
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Liverpool
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United Kingdom
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Manchester
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United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24135509
Citation
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.
Results Reference
derived
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Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.
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