Study of Vilazodone to Treat Social Anxiety Disorder

Sponsor

The Medical Research Network (Other)

Overall Status

Unknown status

CT.gov ID

NCT01712321

Collaborator

Forest Laboratories (Industry)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Social Anxiety Disorder	Drug: Vilazodone Drug: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2014

Anticipated Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vilazodone Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks	Drug: Vilazodone Vilazodone 20mg or 40mg taken once daily by mouth Other Names: Viibryd
Placebo Comparator: Placebo Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks	Drug: Placebo Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth Other Names: Matching placebo

Arm

Intervention/Treatment

Experimental: Vilazodone

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

Drug: Vilazodone

Vilazodone 20mg or 40mg taken once daily by mouth

Other Names:

Viibryd

Placebo Comparator: Placebo

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

Drug: Placebo

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

Other Names:

Matching placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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.
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.
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.