Study of Vilazodone to Treat Social Anxiety Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
The Medical Research Network
ClinicalTrials.gov Identifier:
NCT01712321
First received: October 18, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Social Anxiety Disorder
Drug: Vilazodone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study

Resource links provided by NLM:


Further study details as provided by The Medical Research Network:

Primary Outcome Measures:
  • Change in Liebowitz Social Anxiety Scale (LSAS) - total score [ Time Frame: Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Study Endpoint: minimum 6 weeks - maximum 12 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Study Endpoint: minimum 6 weeks - maximum 12 weeks ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Matching 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712321

Locations
United States, New York
The Medical Research Network, LLC
New York, New York, United States, 10128
Sponsors and Collaborators
The Medical Research Network
Forest Laboratories
Investigators
Principal Investigator: Michael R. Liebowitz, MD The Medical Research Network, LLC
  More Information

No publications provided

Responsible Party: The Medical Research Network
ClinicalTrials.gov Identifier: NCT01712321     History of Changes
Other Study ID Numbers: VII-IT-07
Study First Received: October 18, 2012
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Medical Research Network:
Social Anxiety Disorder
Social Anxiety
Social Phobia
SAD

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014