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Study of Vilazodone to Treat Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vilazodone
Placebo
Sponsored by
The Medical Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social Anxiety Disorder, Social Anxiety, Social Phobia, SAD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Medical Research Network, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vilazodone

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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 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 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 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.
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.

Full Information

First Posted
October 18, 2012
Last Updated
January 16, 2014
Sponsor
The Medical Research Network
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01712321
Brief Title
Study of Vilazodone to Treat Social Anxiety Disorder
Official Title
Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Medical Research Network
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Social Anxiety Disorder, Social Anxiety, Social Phobia, SAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vilazodone
Arm Type
Experimental
Arm Description
Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Other Intervention Name(s)
Viibryd
Intervention Description
Vilazodone 20mg or 40mg taken once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching placebo
Intervention Description
Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth
Primary Outcome Measure Information:
Title
Change in Liebowitz Social Anxiety Scale (LSAS) - total score
Description
All subjects randomized to drug or placebo and returning for at least one subsequent visit will be included in the primary efficacy analyses.
Time Frame
Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks
Secondary Outcome Measure Information:
Title
Responder rate, as defined by Clinical Global Impression of Improvement score of 1 or 2
Description
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.
Time Frame
Study Endpoint: minimum 6 weeks - maximum 12 weeks
Title
Change in the Clinical Global Impression of Severity of Illness score
Description
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.
Time Frame
Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Title
Change on the LSAS anxiety and avoidance subscales
Description
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.
Time Frame
Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Title
Change in Hamilton Depression scale total
Description
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.
Time Frame
Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Title
Change in Hamilton Anxiety scale total
Description
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.
Time Frame
Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Title
Subject-assessed responder rate
Description
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.
Time Frame
Study Endpoint: minimum 6 weeks - maximum 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R. Liebowitz, MD
Organizational Affiliation
The Medical Research Network, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27057414
Citation
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.
Results Reference
derived

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Study of Vilazodone to Treat Social Anxiety Disorder

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