Phase 3
N=404
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01844115 ↗Enrolled (actual)
404
Serious AEs
0.7%
Results posted
Dec 2019
Primary outcome: Primary: Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score — 14.7; 11.3 Score on Scale — p=0.0048
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
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
14.7; 11.3 | 0.0048 sig |
| SECONDARY Change From Baseline in the Sheehan Disability Scale (SDS) Total Score |
9.2; 7.4 | 0.0236 sig |
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 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01844115). 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.