The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
511
Change in HAM-A Total Score
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.
Time frame: Baseline to week 8
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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
...and 40 more locations