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

NCT ID: NCT00314210

Last Updated: 2009-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

575 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Quetiapine SR

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Martin Brecher, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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United States Australia Canada Finland Germany Hungary Indonesia Philippines Russia South Korea United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24135509 (View on PubMed)

Other Identifiers

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EUDRACT Number: 2005-005055-18

Identifier Type: -

Identifier Source: secondary_id

D1448C00012

Identifier Type: -

Identifier Source: org_study_id

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