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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00314210




Registration number
NCT00314210
Ethics application status
Date submitted
11/04/2006
Date registered
13/04/2006
Date last updated
25/03/2009

Titles & IDs
Public title
Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.
Scientific 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
Secondary ID [1] 0 0
EUDRACT Number: 2005-005055-18
Secondary ID [2] 0 0
D1448C00012
Universal Trial Number (UTN)
Trial acronym
PLATINUM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time from randomisation to occurrence of an anxiety event
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Occurrence of an anxiety event
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Change from randomisation in HAM-A/CGI-S scores
Timepoint [2] 0 0
Secondary outcome [3] 0 0
In HAM-A psychic/somatic anxiety factor scores
Timepoint [3] 0 0
Secondary outcome [4] 0 0
In MADRS total score and in MADRS item 10 score (suicidal thought)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS
Timepoint [5] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Brisbane
Recruitment hospital [2] 0 0
Research Site - Everton Park
Recruitment hospital [3] 0 0
Research Site - West Burleigh
Recruitment hospital [4] 0 0
Research Site - Malvern
Recruitment hospital [5] 0 0
Research Site - Prahran
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Everton Park
Recruitment postcode(s) [3] 0 0
- West Burleigh
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
- Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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Missouri
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New Jersey
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New York
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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United States of America
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Virginia
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Canada
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Alberta
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Finland
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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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Germany
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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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Hungary
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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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Indonesia
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West Java
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Indonesia
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Jakarta
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Korea, Republic of
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Seoul
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Philippines
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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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Russian Federation
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Moscow
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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United Kingdom
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Berkshire
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West Sussex
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United Kingdom
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Blackpool
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Bolton
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Cardiff
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United Kingdom
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Chorley
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Coventry
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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

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00314210
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Martin Brecher, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00314210