The purpose of this study is to determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Vilazodone 20mg or 40mg taken once daily by mouth
Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth
The Medical Research Network, LLC
New York, New York, United States
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.
Time frame: Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
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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.
Time frame: 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.
Time frame: Study Endpoint: minimum 6 weeks - maximum 12 weeks