Experimental Medication For the Treatment of Generalized Anxiety Disorder

Phase 3

Completed

• Conditions: Anxiety Disorder

• Registration Number: NCT00097708
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2004-11-29
• Study First Submitted QC: 2004-11-29
• Study First Posted: 2004-11-30
• Study Completion: 2005-12
• Results First Submitted: 2011-09-14
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-01
• Last Update Submitted: 2014-10-01
• Results First Posted: 2014-10-03
• Last Update Posted: 2014-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HAM-A Total Score	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.

Trial Locations

Locations (49)

Birmingham Research Group, Inc.; 🇺🇸 Birmingham, Alabama, United States

Crest Clinical Trials, Inc.; 🇺🇸 Anaheim, California, United States

Southwesten Research, Inc.; 🇺🇸 Beverly Hills, California, United States

Southwestern Research Institute; 🇺🇸 Burbank, California, United States

University of California - San Diego - Dept of Psychiatry; 🇺🇸 San Diego, California, United States

Clinical Innovations; 🇺🇸 Santa Ana, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Alpine Clinical Research Center; 🇺🇸 Boulder, Colorado, United States

New Britain General Hospital; 🇺🇸 New Britain, Connecticut, United States

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