Generalized Anxiety Disorder Adjunct Study

NCT ID: NCT00534599

Last Updated: 2011-04-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

409 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-09-30

Brief Summary

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This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo

Detailed Description

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Conditions

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Anxiety Anxiety Disorders Anxiety Neuroses Anxiety States

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Adjunctive Placebo Seroquel XR to anxiety treatment

Group Type OTHER

Placebo

Intervention Type DRUG

oral

2

Adjunctive Seroquel XR to anxiety treatment

Group Type EXPERIMENTAL

quetiapine fumarate XR

Intervention Type DRUG

oral

Interventions

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Placebo

oral

Intervention Type DRUG

quetiapine fumarate XR

oral

Intervention Type DRUG

Other Intervention Names

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Seroquel XR

Eligibility Criteria

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Inclusion Criteria

Provision of Informed Consent

* Documented diagnosis of Generalized Anxiety Disorder
* Female patients must not be pregnant and be willing to use a reliable method of birth control
* Be able to understand and comply with study requirements

Exclusion Criteria

Other psychiatric disorders that could confound the study results, as judged by the study doctor

* Moderate to severe depression
* Other clinically relevant diseases, as judged by the study doctor
* Medication that you are taking, as judged by the study doctor
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

Responsible Party

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AstraZeneca

Principal Investigators

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Martin Brecher, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Birmingham, Alabama, United States

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Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Encino, California, 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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San Diego, California, United States

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San Francisco, California, United States

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Sherman Oaks, California, United States

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Bradenton, Florida, United States

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Dayton, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Chicago, Illinois, United States

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Lafayette, Indiana, United States

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Merrillville, Indiana, United States

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Terre Haute, Indiana, United States

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Prairie Village, Kansas, United States

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Owenboro, Kentucky, United States

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New Orleans, Louisiana, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Cherry Hill, New Jersey, United States

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Clementon, New Jersey, United States

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Brooklyn, New York, United States

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Cedarhurst, New York, United States

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Fresh Meadows, 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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Staten Island, New York, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Witchita Falls, Texas, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Countries

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United States

References

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Khan A, Atkinson S, Mezhebovsky I, She F, Leathers T, Pathak S. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: a randomized, double-blind study. Ann Clin Psychiatry. 2014 Feb;26(1):3-18.

Reference Type DERIVED
PMID: 24660224 (View on PubMed)

Khan A, Atkinson S, Mezhebovsky I, She F, Leathers T, Pathak S. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: a randomized, double-blind study. Ann Clin Psychiatry. 2013 Nov;25(4):E7-22.

Reference Type DERIVED
PMID: 24199224 (View on PubMed)

Other Identifiers

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D1441L00016

Identifier Type: -

Identifier Source: org_study_id

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