Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
- Registration Number
- NCT01844115
- Lead Sponsor
- Forest Laboratories
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 415
- Male or female outpatient, 18-70 years of age
- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder
- Minimum score of 20 on Hamilton Rating Scale for Anxiety
-
Women who are pregnant or who will be breastfeeding during the study
-
Patients with a history of:
- Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
- Any depressive episode with psychotic or catatonic features
- Panic disorder with or without agoraphobia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Dose-matched placebo tablets, oral administration Vilazodone Vilazodone Vilazodone tablets, oral administration
- Primary Outcome Measures
Name Time Method Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score Baseline to Week 8 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Sheehan Disability Scale (SDS) Total Score Baseline to Week 8 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).
Trial Locations
- Locations (36)
Forest Investigative Site 023
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 013
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 001
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 026
🇺🇸Rancho Mirage, California, United States
Forest Investigative Site 030
🇺🇸Bradenton, Florida, United States
Forest Investigative Site 031
🇺🇸Dallas, Texas, United States
Forest Investigative Site 032
🇺🇸Orlando, Florida, United States
Forest Investigative Site 005
🇺🇸Cherry Hill, New Jersey, United States
Forest Investigative Site 025
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 015
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 010
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 016
🇺🇸Bellevue, Washington, United States
Forest Investigative Site 024
🇺🇸Seattle, Washington, United States
Forest Investigative Site 002
🇺🇸Cedarhurst, New York, United States
Forest Investigative Site 004
🇺🇸Mount Kisco, New York, United States
Forest Investigative Site 017
🇺🇸Sherman Oaks, California, United States
Forest Investigative Site 035
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 021
🇺🇸West Palm Beach, Florida, United States
Forest Investigative Site 018
🇺🇸Decatur, Georgia, United States
Forest Investigative Site 022
🇺🇸Hoffman Estates, Illinois, United States
Forest Investigative Site 014
🇺🇸Berlin, New Jersey, United States
Forest Investigative Site 019
🇺🇸Dayton, Ohio, United States
Forest Investigative Site 003
🇺🇸New York, New York, United States
Forest Investigative Site 020
🇺🇸New York, New York, United States
Forest Investigative Site 037
🇺🇸Allentown, Pennsylvania, United States
Forest Investigative Site 011
🇺🇸Media, Pennsylvania, United States
Forest Investigative Site 012
🇺🇸Herndon, Virginia, United States
Forest Investigative Site 008
🇺🇸Portland, Oregon, United States
Forest Investigative Site 028
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 036
🇺🇸Beverly Hills, California, United States
Forest Investigative Site 009
🇺🇸Oceanside, California, United States
Forest Investigative Site 034
🇺🇸Sherman Oaks, California, United States
Forest Investigative Site 029
🇺🇸Gainesville, Florida, United States
Forest Investigative Site 007
🇺🇸New York, New York, United States
Forest Investigative Site 027
🇺🇸Bronx, New York, United States
Forest Investigative Site 033
🇺🇸Memphis, Tennessee, United States