Phase 3
N=673
Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01629966 ↗Enrolled (actual)
673
Serious AEs
0.3%
Results posted
Dec 2019
Primary outcome: Primary: Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score — 13.1; 12.0; 11.2 Score on scale — p=0.0830
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Vilazodone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
13.1; 12.0; 11.2 | 0.0830 |
| SECONDARY Change From Baseline in the Sheehan Disability Scale (SDS) Total Score |
8.4; 7.7; 6.7 | 0.0536 |
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)
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01629966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.