Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients. (PLATINUM)

March 24, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

575

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

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia
        • Research Site
      • Everton Park, Queensland, Australia
        • Research Site
      • West Burleigh, Queensland, Australia
        • Research Site
    • Victoria
      • Malvern, Victoria, Australia
        • Research Site
      • Prahran, Victoria, Australia
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • New Brunswick
      • Bathurst, New Brunswick, Canada
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada
        • Research Site
      • Kingston, Ontario, Canada
        • Research Site
      • Orleans, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • Waterloo, Ontario, Canada
        • Research Site
    • Quebec
      • Gatineau, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Joensuu, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Pori, Finland
        • Research Site
      • Seinajoki, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Gottingen, Germany
        • Research Site
      • Jena, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Naumburg, Germany
        • Research Site
      • Nurnberg, Germany
        • Research Site
      • Schwerin, Germany
        • Research Site
      • Siegen, Germany
        • Research Site
  • Hungary
      • Balassagyarmat, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Kecskemét, Hungary
        • Research Site
      • Nyíregyháza, Hungary
        • Research Site
  • Indonesia
      • Jakarta, Indonesia
        • Research Site
    • West Java
      • Bandung, West Java, Indonesia
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Davao City, Philippines
        • Research Site
      • Mandaluyong City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Saratov, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • United Kingdom
      • Blackpool, United Kingdom
        • Research Site
      • Bolton, United Kingdom
        • Research Site
      • Cardiff, United Kingdom
        • Research Site
      • Chorley, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Hamilton, United Kingdom
        • Research Site
      • Liverpool, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
    • Berkshire
      • Reading, Berkshire, United Kingdom
        • Research Site
    • West Sussex
      • Crawley, West Sussex, United Kingdom
        • Research Site
  • United States
    • Arizona
      • Mesa, Arizona, United States
        • Research Site
      • Peoria, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
    • California
      • Fresno, California, United States
        • Research Site
      • La Mesa, California, United States
        • Research Site
      • Oceanside, California, United States
        • Research Site
      • Redlands, California, United States
        • Research Site
    • Florida
      • Coral Springs, Florida, United States
        • Research Site
      • Deland, Florida, United States
        • Research Site
      • Ft Myers, Florida, United States
        • Research Site
      • Gainsville, Florida, United States
        • Research Site
      • Hialeah, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • North Miami, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • St Petersberg, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Columbus, Georgia, United States
        • Research Site
      • Marietta, Georgia, United States
        • Research Site
      • Roswell, Georgia, United States
        • Research Site
    • Idaho
      • Coeur D'alene, Idaho, United States
        • Research Site
    • Illinois
      • Hoffman Estates, Illinois, United States
        • Research Site
      • Libertyville, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
      • Lafayette, Indiana, United States
        • Research Site
      • Valparaiso, Indiana, United States
        • Research Site
    • Kansas
      • Prairie Village, Kansas, United States
        • Research Site
    • Kentucky
      • Owensboro, Kentucky, United States
        • Research Site
      • Paducah, Kentucky, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
      • Cambridge, Massachusetts, United States
        • Research Site
      • Pittsfield, Massachusetts, United States
        • Research Site
    • Missouri
      • St Charles, Missouri, United States
        • Research Site
    • New Jersey
      • Piscataway, New Jersey, United States
        • Research Site
    • New York
      • Bronx, New York, United States
        • Research Site
      • Cedarhurst, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • Ohio
      • Avon Lake, Ohio, United States
        • Research Site
      • Beechwood, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
      • Middleburg Heights, Ohio, United States
        • Research Site
      • Toledo, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Research Site
      • Havertown, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • South Carolina
      • N. Charleston, South Carolina, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
    • Texas
      • Desoto, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Wichita Falls, Texas, United States
        • Research Site
    • Utah
      • Midvale, Utah, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • Research Site

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:

  • 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.

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time from randomisation to occurrence of an anxiety event

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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

March 1, 2006

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 12, 2006

First Posted (ESTIMATE)

April 13, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1448C00012
  • EUDRACT Number: 2005-005055-18

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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