Phase 3
Completed N=398
Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder
Source: ClinicalTrials.gov NCT01766401 ↗Enrolled (actual)
398
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Change in Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score — 14.9; 13.5 Score on Scale — p=0.0438
◆ Published Evidence
Established
25citations · ~2 / year
Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study.
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).
Linked Publications (2)
-
Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study.
-
Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
14.9; 13.5 | 0.0438 sig |
| SECONDARY Change From Baseline in the Sheehan Disability Scale (SDS) Total Score |
10.1; 7.8 | 0.0868 |
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
- Patients with a history of meeting DSM-IV-TR criteria for:
- any manic, 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 cognitive disorders
- Patients who are considered a suicide risk
Data sourced from ClinicalTrials.gov (NCT01766401) and the linked publication. 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. Informational only — not medical advice.