Experimental Medication For the Treatment of Generalized Anxiety Disorder

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

Completed

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Key information

Conditions

Anxiety Disorder Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham Research Group, Inc., Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

experimental anti-anxiety drug

Drug

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study title

A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder

Important dates

Study start: 2004
Study completion: 2005
First posted: Nov 30, 2004
Registry last updated: Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed