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: October 1, 2014
Last verified: October 2014
  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:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Change in HAM-A Total Score [ Time Frame: Baseline to week 8 ] [ Designated as safety issue: No ]
    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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: September 14, 2011
Last Updated: October 1, 2014
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
Disease
Mental Disorders
Pathologic Processes
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014