Study of Vilazodone to Treat Social Anxiety Disorder

The Medical Research Network

Status: Unknown

Conditions: Social Anxiety Disorder

Treatments: Drug: Placebo; Drug: Vilazodone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01712321

VII-IT-07

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Vilazodone

Experimental group

Description:

Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks

Treatment:

Drug: Vilazodone

Placebo

Placebo Comparator group

Description:

Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks

Treatment:

Drug: Placebo