Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

Study Overview
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Brief Summary
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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)

Official Title
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A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Drug: Placebo
* Drug: Vilazodone
* Drug: Vilazodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Dose-matched placebo one per day, oral administration | Drug: Placebo<br>* Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,<br>|
| Experimental: Vilazadone 20mg<br>Vilazodone 20mg once per day, oral administration. | Drug: Vilazodone<br>* Vilazodone, 20mg, oral administration once per day.<br>|
| Experimental: Vilazodone 40mg<br>Vilazodone 40mg once per day, oral administration | Drug: Vilazodone<br>* Vilazodone, 40mg, oral administration once per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | 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. | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Sheehan Disability Scale (SDS) Total Score | 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). | Baseline to Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder, GAD