Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder
NCT ID: NCT00389064
Last Updated: 2012-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
450 participants
INTERVENTIONAL
2006-09-30
2008-04-30
Brief Summary
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PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Quetapine XR
Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.
Quetiapine XR
Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period.
Placebo
Matching placebo tablets orally administered once daily.
Placebo
Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.
Interventions
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Quetiapine XR
Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period.
Placebo
Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.
Eligibility Criteria
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Inclusion Criteria
* Absence of current episode of major depression.
Exclusion Criteria
* Serious suicidal risk, uncontrolled hypertension, substance or alcohol abuse.
* A current diagnosis of cancer or current or past diagnosis of stroke.
66 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Ricardo Ruiz, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Fort Myers, Florida, United States
Research Site
Gainsville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Roswell, Georgia, United States
Research Site
Boston, Massachusetts, United States
Research Site
Brooklyn, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Avon Lake, Ohio, United States
Research Site
Eugene, Oregon, United States
Research Site
Jenkintown, Pennsylvania, United States
Research Site
Austin, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Tartu, Estonia, Estonia
Research Site
Tallinn, , Estonia
Research Site
Viljandi, , Estonia
Research Site
Bialystok, , Poland
Research Site
Gorlice, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Leszno, , Poland
Research Site
Skorzewo, , Poland
Research Site
Torun, , Poland
Research Site
Wroclaw, , Poland
Research Site
Arkhangelsk, , Russia
Research Site
Izhevsk, , Russia
Research Site
Lipetsk, , Russia
Research Site
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Perm, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saratov, , Russia
Research Site
Stavropol, , Russia
Research Site
Voronezh, , Russia
Research Site
Hlevakha, Kyiv Oblast, Ukraine
Research Site
Dnipro, , Ukraine
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Donetsk, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Luhansk, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Vinnitsa, , Ukraine
Countries
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References
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Mezhebovsky I, Magi K, She F, Datto C, Eriksson H. Double-blind, randomized study of extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder. Int J Geriatr Psychiatry. 2013 Jun;28(6):615-25. doi: 10.1002/gps.3867. Epub 2012 Oct 16.
Other Identifiers
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EUDRACT No: 2006-001195-21
Identifier Type: -
Identifier Source: secondary_id
D1448C00015
Identifier Type: -
Identifier Source: org_study_id
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