AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)

NCT ID: NCT00808249

Last Updated: 2011-06-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

725 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-05-31

Brief Summary

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The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A-AZD7325 2mg

AZD7325 2mg BID

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

2 tablets taken twice a day for 28 days

B-AZD7325 5mg

AZD7325 5mg BID

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

2 tablets taken twice a day for 28 days

C-AZD7325 10mg

AZD7325 10mg QD

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

2 tablets taken twice a day for 28 days

D-Placebo

Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

2 tablets taken twice a day for 28 days

Interventions

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AZD7325

2 tablets taken twice a day for 28 days

Intervention Type DRUG

AZD7325

2 tablets taken twice a day for 28 days

Intervention Type DRUG

AZD7325

2 tablets taken twice a day for 28 days

Intervention Type DRUG

Placebo

2 tablets taken twice a day for 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent before any study-related procedures start.
* 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 lifetime history of schizophrenia or other psychotic disorders
* Patient has a history of seizures or seizure disorder.
* Patient is pregnant or breast feeding.
* Patient has received electroconvulsive treatment (ECT) in the past.
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 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

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Tucson, Arizona, United States

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Arcadia, California, United States

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Beverly Hills, California, United States

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Cerritos, California, United States

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Chino, California, United States

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Encino, California, United States

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Los Alamitos, California, United States

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Novato, California, United States

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Oceanside, California, United States

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San Diego, California, United States

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Norwich, Connecticut, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Saint Petersberg, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Smyrna, Georgia, United States

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Libertyville, Illinois, United States

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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

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Fresh Meadows, New York, United States

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Mount Kisco, 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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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, 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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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Jenkintown, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Memphis, Tennessee, United States

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Friendswood, 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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Woodstock, Vermont, United States

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Herndon, Virginia, United States

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Spokane, Washington, United States

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Middleton, Wisconsin, United States

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Countries

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United States

Other Identifiers

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D1140C00006

Identifier Type: -

Identifier Source: org_study_id

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