Clinical Trial: Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.

Brief Summary: SSRI's are considered first-line treatments for GSP, however many patients continue to have significant symptoms despite an adequate trial of an SSRI. Topiramate, a drug, which targets the glutamate system in the brain, has been shown to improve symptoms of social phobia when used on its own and has also been used as an additive treatment in other anxiety disorders. This study will test the efficacy of adding topiramate to a subject's current SSRI in cases of GSP which are considered to be treatment-resistant.

Detailed Summary:
Sponsor: Hamilton Health Sciences Corporation

Current Primary Outcome:

  • Clinical Global Impression - Improvement (CGI-I) ≤ 2 [ Time Frame: 12 weeks ]
  • Mean change in Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 12 weeks ]


Original Primary Outcome:

  • Clinical Global Impression - Improvement (CGI-I) ≤ 2
  • Mean change in Liebowitz Social Anxiety Scale (LSAS)


Current Secondary Outcome:

  • Social Phobia Scale [ Time Frame: 12 weeks ]
  • Social Phobia Inventory [ Time Frame: 12 weeks ]
  • Clinical Global Impression -Severity [ Time Frame: 12 weeks ]
  • Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale [ Time Frame: 12 weeks ]
  • Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks ]
  • Beck Depression Inventory [ Time Frame: 12 weeks ]
  • Beck Anxiety Inventory [ Time Frame: 12 weeks ]


Original Secondary Outcome:

  • Mean change from baseline in the following measures:
  • Social Phobia Scale
  • Social Phobia Ineventory
  • Clinical Global Impression -Severity
  • Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale
  • Montgomery Asberg Depression Rating Scale
  • Beck Depression Ineventory
  • Beck Anxiety Inventory


Information By: McMaster University

Dates:
Date Received: September 14, 2005
Date Started: March 2004
Date Completion: December 2017
Last Updated: December 12, 2016
Last Verified: December 2016