Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder

NCT ID: NCT00329446

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

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-09-30

Brief Summary

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The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder.

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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Generalized Anxiety Disorder

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 Fumarate

Intervention Type DRUG

Escitalopram oxylate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient has a documented clinical diagnosis of Generalized Anxiety Disorder.
* Be able to understand and comply with the requirements of the study.
* Able to understand and provide written informed consent

Exclusion Criteria

* Patients (female) must not be pregnant or lactating
* Current or past diagnosis of stroke or transient ischemic attack (TIA).
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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Anders Neijber, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Birmingham, Alabama, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Burbank, California, United States

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La Mesa, California, United States

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Orange, California, United States

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Pasadena, California, United States

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San Diego, California, United States

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Sherman Oaks, California, United States

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Upland, California, United States

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Wildomar, California, United States

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New Britain, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Bradenton, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, 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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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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Edwardsville, Illinois, United States

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Merrillville, Indiana, United States

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Terre Haute, Indiana, United States

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Newton, Kansas, United States

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Prairie Village, Kansas, United States

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Owensboro, Kentucky, United States

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Lake Charles, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Haverhill, Massachusetts, United States

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Okemos, Michigan, United States

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Saint Paul, Minnesota, United States

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St Louis, Missouri, United States

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Kenilworth, New Jersey, United States

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Princeton, New Jersey, United States

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Toms River, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Salem, Oregon, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Kirkland, Washington, United States

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Spokane, Washington, United States

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Morgantown, West Virginia, United States

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Countries

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United States

References

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Montgomery SA, Locklear JC, Svedsater H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.

Reference Type DERIVED
PMID: 24394383 (View on PubMed)

Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6.

Reference Type DERIVED
PMID: 22143997 (View on PubMed)

Merideth C, Cutler AJ, She F, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate monotherapy in the acute treatment of generalized anxiety disorder: a randomized, placebo controlled and active-controlled study. Int Clin Psychopharmacol. 2012 Jan;27(1):40-54. doi: 10.1097/YIC.0b013e32834d9f49.

Reference Type DERIVED
PMID: 22045039 (View on PubMed)

Other Identifiers

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GOLD

Identifier Type: -

Identifier Source: secondary_id

D1448C00010

Identifier Type: -

Identifier Source: org_study_id

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