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Experimental Medication For the Treatment of Generalized Anxiety Disorder

This study has been completed.
Information provided by:
Jazz Pharmaceuticals Identifier:
First received: November 29, 2004
Last updated: October 1, 2014
Last verified: October 2014
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Condition Intervention Phase
Anxiety Disorder Drug: experimental anti-anxiety drug Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder

Resource links provided by NLM:

Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • 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.

Enrollment: 511
Study Start Date: November 2004
Estimated Study Completion Date: December 2005
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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00097708

  Show 50 Study Locations
Sponsors and Collaborators
Jazz Pharmaceuticals
Study Chair: Murray Stein, MD University of California, San Diego
  More Information Identifier: NCT00097708     History of Changes
Other Study ID Numbers: JZP 04-001-01
Study First Received: November 29, 2004
Results First Received: September 14, 2011
Last Updated: October 1, 2014

Keywords provided by Jazz Pharmaceuticals:
Double Blind, Placebo controlled, Safety and Efficacy
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on September 21, 2017