AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)
NCT ID: NCT00808249
Last Updated: 2011-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
725 participants
INTERVENTIONAL
2008-12-31
2009-05-31
Brief Summary
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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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A-AZD7325 2mg
AZD7325 2mg BID
AZD7325
2 tablets taken twice a day for 28 days
B-AZD7325 5mg
AZD7325 5mg BID
AZD7325
2 tablets taken twice a day for 28 days
C-AZD7325 10mg
AZD7325 10mg QD
AZD7325
2 tablets taken twice a day for 28 days
D-Placebo
Placebo
Placebo
2 tablets taken twice a day for 28 days
Interventions
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AZD7325
2 tablets taken twice a day for 28 days
AZD7325
2 tablets taken twice a day for 28 days
AZD7325
2 tablets taken twice a day for 28 days
Placebo
2 tablets taken twice a day for 28 days
Eligibility Criteria
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Inclusion Criteria
* The patient is previously diagnosed with Generalized Anxiety Disorder.
* The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.
Exclusion Criteria
* Patient has a history of seizures or seizure disorder.
* Patient is pregnant or breast feeding.
* Patient has received electroconvulsive treatment (ECT) in the past.
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca Pharmaceuticals
Principal Investigators
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Mark A. Smith, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca
David V. Sheehan
Role: PRINCIPAL_INVESTIGATOR
University of South Florida College of Medicine
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Arcadia, California, United States
Research Site
Beverly Hills, California, United States
Research Site
Cerritos, California, United States
Research Site
Chino, California, United States
Research Site
Encino, California, United States
Research Site
Los Alamitos, California, United States
Research Site
Novato, California, United States
Research Site
Oceanside, California, United States
Research Site
San Diego, California, United States
Research Site
Norwich, Connecticut, United States
Research Site
Fort Myers, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Saint Petersberg, Florida, United States
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Tampa, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Marietta, Georgia, United States
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Smyrna, Georgia, United States
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Libertyville, Illinois, United States
Research Site
Park Ridge, Illinois, United States
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Indianapolis, Indiana, United States
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Overland Park, Kansas, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Cambridge, Massachusetts, United States
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St Louis, Missouri, United States
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Clementon, New Jersey, United States
Research Site
Fresh Meadows, New York, United States
Research Site
Mount Kisco, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Bismarck, North Dakota, United States
Research Site
Beechwood, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Middleburg Heights, Ohio, United States
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Oklahoma City, Oklahoma, United States
Research Site
Portland, Oregon, United States
Research Site
Jenkintown, Pennsylvania, United States
Research Site
Norristown, Pennsylvania, United States
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Memphis, Tennessee, United States
Research Site
Friendswood, Texas, United States
Research Site
San Antonio, Texas, United States
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Salt Lake City, Utah, United States
Research Site
Woodstock, Vermont, United States
Research Site
Herndon, Virginia, United States
Research Site
Spokane, Washington, United States
Research Site
Middleton, Wisconsin, United States
Countries
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Other Identifiers
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D1140C00006
Identifier Type: -
Identifier Source: org_study_id
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