Study of Vilazodone to Treat Social Anxiety Disorder

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

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

Study Overview

• Status: Unknown
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Drug: Vilazodone; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The Medical Research Network
• Collaborators: Forest Laboratories
• Investigators: Principal Investigator: Michael R. Liebowitz, MD, The Medical Research Network, LLC

Publications and helpful links

General Publications

• Careri JM, Draine AE, Hanover R, Liebowitz MR. A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Vilazodone in Generalized Social Anxiety Disorder. Prim Care Companion CNS Disord. 2015 Nov 26;17(6):10.4088/PCC.15m01831. doi: 10.4088/PCC.15m01831. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 19, 2012
• First Posted (Estimate): October 23, 2012

Study Record Updates

• Last Update Posted (Estimate): January 20, 2014
• Last Update Submitted That Met QC Criteria: January 16, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Social Anxiety; Social Phobia; Social Anxiety Disorder; SAD
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vilazodone Hydrochloride
• Other Study ID Numbers: VII-IT-07