Experimental Medication For the Treatment of Generalized Anxiety Disorder

NCT ID: NCT00097708

Last Updated: 2014-10-03

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

PHASE3

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Detailed Description

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Protocol 04-001-01

The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).

The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.

Recruiting: Participants are currently being recruited and enrolled.

Conditions

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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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experimental anti-anxiety drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.

Exclusion Criteria

* No other primary psychiatric diagnosis besides GAD.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jazz Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Murray Stein, MD

Role: STUDY_CHAIR

University of California, San Diego

Locations

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Birmingham Research Group, Inc.

Birmingham, Alabama, United States

Site Status

Crest Clinical Trials, Inc.

Anaheim, California, United States

Site Status

Southwesten Research, Inc.

Beverly Hills, California, United States

Site Status

Southwestern Research Institute

Burbank, California, United States

Site Status

University of California - San Diego - Dept of Psychiatry

San Diego, California, United States

Site Status

Clinical Innovations

Santa Ana, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Alpine Clinical Research Center

Boulder, Colorado, United States

Site Status

New Britain General Hospital

New Britain, Connecticut, United States

Site Status

Florida Clinical Research Center

Bradenton, Florida, United States

Site Status

ACT Clinical Research

DeLand, Florida, United States

Site Status

University Clinical Research DeLand, Inc.

DeLand, Florida, United States

Site Status

Sarkis Clinical Trials

Gainsville, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

Meridien Research

St. Petersburg, Florida, United States

Site Status

Institute of Research in Psychiatry

Tampa, Florida, United States

Site Status

Janus Center for Psychiatric Research

West Palm Beach, Florida, United States

Site Status

Atlanta Institute of Medicine and Research

Marietta, Georgia, United States

Site Status

Radiant Research

Boise, Idaho, United States

Site Status

American Medical Research, Inc.

Oak Brook, Illinois, United States

Site Status

Peak Medical Research, LLC

Owensboro, Kentucky, United States

Site Status

New Orlean Medical Institute

Metairie, Louisiana, United States

Site Status

Brentwood Research Institute

Shreveport, Louisiana, United States

Site Status

Pharmasite Research, Inc.

Baltimore, Maryland, United States

Site Status

McLean Hospital

Belmont, Massachusetts, United States

Site Status

Pivotal Research Centers - Detroit

Royal Oak, Michigan, United States

Site Status

MedClin Research

St Louis, Missouri, United States

Site Status

CNS Research Institute (CRI)

Clementon, New Jersey, United States

Site Status

ClinSearch, Inc.

Kenilworth, New Jersey, United States

Site Status

Princeton Medical Institute

Princeton, New Jersey, United States

Site Status

Social Psychiatry Research Institute

Brooklyn, New York, United States

Site Status

Midwest Clinical Research Center

Dayton, Ohio, United States

Site Status

Neurology and Neuroscience Center of Ohio

Toledo, Ohio, United States

Site Status

IPS Research Company

Oklahoma City, Oklahoma, United States

Site Status

Laureate Psychiatric Clinic and Hospital

Tulsa, Oklahoma, United States

Site Status

Oregon Center for Clinical Investigations, Inc.

Eugene, Oregon, United States

Site Status

Suburban Research Associates

Media, Pennsylvania, United States

Site Status

CNS Research Institute

Philadelphia, Pennsylvania, United States

Site Status

Southeast Health Consultants, LLC

Charleston, South Carolina, United States

Site Status

CNS, Inc.

Memphis, Tennessee, United States

Site Status

Clinical Research Associates, Inc.

Nashville, Tennessee, United States

Site Status

FutureSearch Trials

Austin, Texas, United States

Site Status

Research Across America

Dallas, Texas, United States

Site Status

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Site Status

Lifetree Clinical Research

Salt Lake City, Utah, United States

Site Status

Comprehensive Neuroscience of Northern Virginia

Falls Church, Virginia, United States

Site Status

Dominion Clinical Research, Inc.

Midlothian, Virginia, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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JZP 04-001-01

Identifier Type: -

Identifier Source: org_study_id

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