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

August 31, 2020 updated by: McMaster University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1B7
        • MacAnxiety Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatient with primary DSM-IV GSP
  • Completion of an adequate trial (14 wks) of open, flexible dose SSRI treatment (fluoxetine 80mg/day, paroxetine 60mg/day, fluvoxamine 300 mg/day, sertraline 200mg/day, citalopram 60mg/day, escitalopram 30mg/day)
  • Non or partial response to SSRI treatment (CGI-S > 4, LSAS > 40)

Exclusion Criteria:

  • Any other DSM-IV Axis I primary diagnosis
  • Meeting DSM-IV criteria for body dysmorphic disorder, eating disorder or current alcohol/substance abuse
  • A lifetime history of bipolar affective disorder
  • A Hx of schizophrenia/psychotic disorders, delirium, dementia, or amnestic/other cognitive disorders
  • Borderline/antisocial personality disorder
  • A comorbid Axis II cluster A personality disorder
  • Hx of > 3 adequate trials with an SSRI
  • score of > 4 on MADRS q.10
  • Current increased risk of suicide
  • Prior use of or an allergy to topiramate
  • Participation in any clinical trial 30 days prior to entering the study
  • Unable to tolerate being free of or shows signs of withdrawal benzodiazepines for 4 weeks
  • Hx of seizures, kidney stones or thyroid problems
  • BMI < 20

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
25 - 400 mg/day x 12 weeks
Experimental: 1
Topiramate 25 - 400 mg/day x 12 weeks
Drug: Topiramate
25 - 400 mg/day x 12 weeks
Other Names:
  • Topomax

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Hamilton Health Sciences Corporation
Janssen-Ortho Inc., Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2004

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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