Study of Vilazodone to Treat Social Anxiety Disorder

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults.

Detailed Description
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The proposed study is a 12 week double-blind, placebo-controlled trial in which daily doses of vilazodone 20 to 40 mg/day or matching placebo will be administered on a 1:1 ratio. The study will include 30 outpatients age 18-75 with SAD, generalized subtype who return for at least one post randomization visit where efficacy evaluations are conducted.

Official Title
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Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Drug: Vilazodone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Social Anxiety Disorder, generalized subtype LSAS total score of 70 at visits 1 and 2 Exclusion Criteria: Lifetime history of Bipolar disorder or Schizophrenia Current suicidal risk Current unstable medical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Vilazodone<br>Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks | Drug: Vilazodone<br>* Vilazodone 20mg or 40mg taken once daily by mouth<br>* Other names: Viibryd;|
| Placebo Comparator: Placebo<br>Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks | Drug: Placebo<br>* Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth<br>* Other names: Matching placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Liebowitz Social Anxiety Scale (LSAS) - total score | All subjects randomized to drug or placebo and returning for at least one subsequent visit will be included in the primary efficacy analyses. | Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate, as defined by Clinical Global Impression of Improvement score of 1 or 2 | Responder rate as defined by a CGI Improvement score of 1 (Very Much Improved) or 2 (Much Improved) at study endpoint. Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses. | Study Endpoint: minimum 6 weeks - maximum 12 weeks | 
| Change in the Clinical Global Impression of Severity of Illness score | Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses. | Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks | 
| Change on the LSAS anxiety and avoidance subscales | Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses. | Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks | 
| Change in Hamilton Depression scale total | Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses. | Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks | 
| Change in Hamilton Anxiety scale total | Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses. | Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks | 
| Subject-assessed responder rate | Subject-assessed responder rate, as defined by a Patient Global Impression of Change score of 1 (Very Much Improved) or 2 (Much Improved) at study endpoint. Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses. | Study Endpoint: minimum 6 weeks - maximum 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Anxiety Disorder, Social Anxiety, Social Phobia, SAD