Phase 3 N=398 Randomized Triple-blind Treatment

Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder

Generalized Anxiety Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01766401 ↗

Enrolled (actual)

398

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcome: Primary: Change in Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score — 14.9; 13.5 Score on Scale — p=0.0438

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Vilazadone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Forest Laboratories
Primary completion: Jan 2014

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

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01766401). 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.