Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
- Registration Number
- NCT01629966
- 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
- 680
- Male and female, 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 (GAD)
- Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)
-
Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control
-
History of meeting DSM-IV-TR criteria for any of the following:
- 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
- Obsessive-compulsive disorder
- Schizophrenia, schizoaffective, or other psychotic disorder
- Bulimia or anorexia nervosa
- Presence of borderline personality disorder or antisocial personality disorder
- Mental retardation, dementia, amnesia, or other significant cognitive disorders
-
Patients who are considered a suicide risk
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vilazadone 20mg Vilazodone Vilazodone 20mg once per day, oral administration. Placebo Placebo Dose-matched placebo one per day, oral administration Vilazodone 40mg Vilazodone Vilazodone 40mg once per day, 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 (37)
Forest Investigative Site 001
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 021
🇺🇸Beverly Hills, California, United States
Forest Investigative Site 023
🇺🇸Glendale, California, United States
Forest Investigative Site 011
🇺🇸Paramount, California, United States
Forest Investigative Site 026
🇺🇸Norwich, Connecticut, United States
Forest Investigative Site 027
🇺🇸Waterbury, Connecticut, United States
Forest Investigative Site 005
🇺🇸Delray Beach, Florida, United States
Forest Investigative Site 014
🇺🇸Oakland Park, Florida, United States
Forest Investigative Site 019
🇺🇸South Miami, Florida, United States
Forest Investigative Site 038
🇺🇸Atlanta, Georgia, United States
Scroll for more (27 remaining)Forest Investigative Site 001🇺🇸Birmingham, Alabama, United States