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Study of Vilazodone to Treat Social Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT01712321
Recruitment Status : Unknown
Verified January 2014 by The Medical Research Network.
Recruitment status was:  Active, not recruiting
First Posted : October 23, 2012
Last Update Posted : January 20, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Social Anxiety Disorder 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2012
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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 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


Outcome Measures

Primary Outcome Measures :
  1. Change in Liebowitz Social Anxiety Scale (LSAS) - total score [ Time Frame: 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 :
  1. 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 ]

    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.


  2. 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 ]
    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.

  3. Change on the LSAS anxiety and avoidance subscales [ Time Frame: 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.

  4. Change in Hamilton Depression scale total [ Time Frame: 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.

  5. Change in Hamilton Anxiety scale total [ Time Frame: 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.

  6. Subject-assessed responder rate [ Time Frame: 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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Medical Research Network
ClinicalTrials.gov Identifier: NCT01712321     History of Changes
Other Study ID Numbers: VII-IT-07
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

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

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders
Vilazodone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists