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Experimental Medication For the Treatment of Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00097708
First received: November 29, 2004
Last updated: January 7, 2008
Last verified: January 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Measure improvement of anxiety symptoms.

Secondary Outcome Measures:
  • Remission and response rates of anxiety symptoms.

Estimated Enrollment: 350
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097708

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

No publications provided

ClinicalTrials.gov Identifier: NCT00097708     History of Changes
Other Study ID Numbers: JZP 04-001-01
Study First Received: November 29, 2004
Last Updated: January 7, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013