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Experimental Medication For the Treatment of Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00097708
Recruitment Status : Completed
First Posted : November 30, 2004
Results First Posted : October 3, 2014
Last Update Posted : October 3, 2014
Sponsor:
Information provided by:
Jazz Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Anxiety Disorder Drug: experimental anti-anxiety drug Phase 3

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  (Clinical Trial)
Actual Enrollment : 511 participants
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
Study Start Date : November 2004
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097708


  Show 50 Study Locations
Sponsors and Collaborators
Jazz Pharmaceuticals
Investigators
Study Chair: Murray Stein, MD University of California, San Diego

ClinicalTrials.gov Identifier: NCT00097708     History of Changes
Other Study ID Numbers: JZP 04-001-01
First Posted: November 30, 2004    Key Record Dates
Results First Posted: October 3, 2014
Last Update Posted: October 3, 2014
Last Verified: October 2014

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

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs