Study of Vilazodone to Treat Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01712321
• Other study ID #: VII-IT-07
• Status: Unknown status
• Phase: N/A
• First received: October 18, 2012
• Last updated: January 16, 2014
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: January 2014
• Source: The Medical Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

Drug:
• Vilazodone
Vilazodone 20mg or 40mg taken once daily by mouth
• Placebo
Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth

Locations

Country	Name	City	State
United States	The Medical Research Network, LLC	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The Medical Research Network	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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