Social Anxiety Disorder
Conditions
Keywords
Social Anxiety Disorder, Social Anxiety, Social Phobia, SAD
Brief summary
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
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.
Interventions
DRUGVilazodone
Vilazodone 20mg or 40mg taken once daily by mouth
DRUGPlacebo
Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth
Sponsors
Forest Laboratories
The Medical Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liebowitz Social Anxiety Scale (LSAS) - total score | Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks | All subjects randomized to drug or placebo and returning for at least one subsequent visit will be included in the primary efficacy analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Clinical Global Impression of Severity of Illness score | Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks | 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 on the LSAS anxiety and avoidance subscales | Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks | 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. |
| Responder rate, as defined by Clinical Global Impression of Improvement score of 1 or 2 | Study Endpoint: minimum 6 weeks - maximum 12 weeks | 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. |
| Change in Hamilton Anxiety scale total | Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks | 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. |
| Subject-assessed responder rate | Study Endpoint: minimum 6 weeks - maximum 12 weeks | 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. |
| Change in Hamilton Depression scale total | Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks | 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. |
Countries
United States
Outcome results
None listed