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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182455
Recruitment Status : Terminated (loss of funding)
First Posted : September 16, 2005
Last Update Posted : September 2, 2020
Janssen-Ortho Inc., Canada
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Social Phobia Drug: Topiramate Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.
Actual Study Start Date : March 1, 2004
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias
Drug Information available for: Topiramate

Arm Intervention/treatment
Experimental: 1
Topiramate 25 - 400 mg/day x 12 weeks
Drug: Topiramate
25 - 400 mg/day x 12 weeks
Other Name: Topomax

Placebo Comparator: 2
Drug: Placebo
25 - 400 mg/day x 12 weeks

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

Secondary Outcome Measures :
  1. Social Phobia Scale [ Time Frame: 12 weeks ]
  2. Social Phobia Inventory [ Time Frame: 12 weeks ]
  3. Clinical Global Impression -Severity [ Time Frame: 12 weeks ]
  4. Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale [ Time Frame: 12 weeks ]
  5. Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks ]
  6. Beck Depression Inventory [ Time Frame: 12 weeks ]
  7. Beck Anxiety Inventory [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00182455

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Canada, Ontario
MacAnxiety Research Centre
Hamilton, Ontario, Canada, L8S 1B7
Sponsors and Collaborators
McMaster University
Janssen-Ortho Inc., Canada
Hamilton Health Sciences Corporation
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Principal Investigator: Michael Van Ameringen, MD, FRCPC Hamilton Health Sciences Corporation
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Responsible Party: McMaster University Identifier: NCT00182455    
Other Study ID Numbers: 04-080
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: April 2018
Keywords provided by McMaster University:
Treatment Refractory Generalized Social Phobia
Additional relevant MeSH terms:
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Phobic Disorders
Phobia, Social
Anxiety Disorders
Mental Disorders
Hypoglycemic Agents
Physiological Effects of Drugs