Clinical Trial: Vilazodone for Separation Anxiety Disorder

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Vilazodone for Separation Anxiety Disorder

Brief Summary: The purpose of this study is to determine whether Vilazodone (Viibryd), an SSRI and 5HT1a receptor agonist, is effective in treating Adult Separation Anxiety Disorder over a 12-week treatment course.

Detailed Summary: In this randomized clinical trial, 40 adults with a principal diagnosis of Adult Separation Anxiety Disorder (ASAD) and no major depression or substance abuse disorders will be randomized to 12 weeks of treatment with vilazodone (flexibly dosed) or matched pill placebo. Outcome will be assessed in respect to symptomatic improvement, quality of life, adverse events and safety.
Sponsor: New York State Psychiatric Institute

Current Primary Outcome: Clinical Global Impression-Improvement Scale [ Time Frame: Week 12 ]

Clinical Global Impression-Improvement Scale rating at week 12


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in Hamilton Depression Rating Scale 17-item total score [ Time Frame: Baseline and 12 weeks ]
  • change from baseline in Attachment Style Questionnaire score [ Time Frame: Baseline and 12 weeks ]
  • change from baseline in Quality of Life Enjoyment & Satisfaction Questionnaire [ Time Frame: Baseline and 12 weeks ]
    Changes in Quality of Life Enjoyment & Satisfaction Questionnaire rating.
  • change from baseline on Side Effect Checklist [ Time Frame: Baseline and 12 weeks ]
    To note any side effects
  • change from baseline on Structured Clinical Interview for Separation Anxiety Disorder [ Time Frame: Baseline and 12 weeks ]
  • change from baseline on Adult Separation Anxiety - 27 Scale [ Time Frame: Baseline and 12 weeks ]


Original Secondary Outcome: Same as current

Information By: New York State Psychiatric Institute

Dates:
Date Received: November 26, 2013
Date Started: December 2013
Date Completion: June 2017
Last Updated: January 3, 2017
Last Verified: December 2016