Experimental Medication For the Treatment of Generalized Anxiety Disorder

October 1, 2014 updated by: Jazz Pharmaceuticals

A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

511

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Birmingham Research Group, Inc.
    • California
      • Anaheim, California, United States, 92804
        • Crest Clinical Trials, Inc.
      • Beverly Hills, California, United States, 90210
        • Southwesten Research, Inc.
      • Burbank, California, United States, 91506
        • Southwestern Research Institute
      • San Diego, California, United States, 92103
        • University of California - San Diego - Dept of Psychiatry
      • Santa Ana, California, United States, 92705
        • Clinical Innovations
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Alpine Clinical Research Center
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • New Britain General Hospital
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center
      • DeLand, Florida, United States, 32720
        • ACT Clinical Research
      • DeLand, Florida, United States, 32720
        • University Clinical Research Deland, Inc.
      • Gainsville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Jacksonville, Florida, United States, 32216
        • Clinical Neuroscience Solutions, INC.
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, INC.
      • St. Petersburg, Florida, United States, 33709
        • Meridien Research
      • Tampa, Florida, United States, 33613
        • Institute of Research in Psychiatry
      • West Palm Beach, Florida, United States, 33407
        • Janus Center For Psychiatric Research
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Atlanta Institute of Medicine and Research
    • Idaho
      • Boise, Idaho, United States, 83704
        • Radiant Research
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • American Medical Research, Inc.
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Peak Medical Research, LLC
    • Louisiana
      • Metairie, Louisiana, United States, 70001
        • New Orlean Medical Institute
      • Shreveport, Louisiana, United States, 71101
        • Brentwood Research Institute
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Pharmasite Research, Inc.
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Pivotal Research Centers - Detroit
    • Missouri
      • St. Louis, Missouri, United States, 63118
        • MedClin Research
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • CNS Research Institute (CRI)
      • Kenilworth, New Jersey, United States, 07033
        • ClinSearch, Inc.
      • Princeton, New Jersey, United States, 08540
        • Princeton Medical Institute
    • New York
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research Institute
    • Ohio
      • Dayton, Ohio, United States, 45408
        • Midwest Clinical Research Center
      • Toledo, Ohio, United States, 43623
        • Neurology and Neuroscience Center of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
      • Tulsa, Oklahoma, United States, 74136
        • Laureate Psychiatric Clinic and Hospital
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Center for Clinical Investigations, Inc.
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
      • Philadelphia, Pennsylvania, United States, 19149
        • CNS Research Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Southeast Health Consultants, LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • CNS, Inc.
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Texas
      • Austin, Texas, United States, 78756
        • FutureSearch Trials
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Lake Jackson, Texas, United States, 77566
        • R/D Clinical Research, Inc.
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research
    • Virginia
      • Falls Church, Virginia, United States, 22041
        • Comprehensive Neuroscience of Northern Virginia
      • Midlothian,, Virginia, United States, 23112
        • Dominion Clinical Research, Inc.
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HAM-A Total Score
Time Frame: Baseline to week 8
Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.
Baseline to week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Investigators

  • Study Chair: Murray Stein, MD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

November 29, 2004

First Submitted That Met QC Criteria

November 29, 2004

First Posted (Estimate)

November 30, 2004

Study Record Updates

Last Update Posted (Estimate)

October 3, 2014

Last Update Submitted That Met QC Criteria

October 1, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JZP 04-001-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety Disorder

Clinical Trials on experimental anti-anxiety drug

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe