The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
415
Viibryd
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Time frame: Baseline to Week 8
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).
Time frame: Baseline to Week 8
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Forest Investigative Site 023
Birmingham, Alabama, United States
Forest Investigative Site 013
Phoenix, Arizona, United States
Forest Investigative Site 036
Beverly Hills, California, United States
Forest Investigative Site 001
Costa Mesa, California, United States
Forest Investigative Site 009
Oceanside, California, United States
Forest Investigative Site 026
Rancho Mirage, California, United States
Forest Investigative Site 017
Sherman Oaks, California, United States
Forest Investigative Site 034
Sherman Oaks, California, United States
Forest Investigative Site 030
Bradenton, Florida, United States
Forest Investigative Site 029
Gainesville, Florida, United States
...and 26 more locations