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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder|
- 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.
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||December 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097708
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|Study Chair:||Murray Stein, MD||University of California, San Diego|