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

Sponsor
McMaster University (Other)
Overall Status
Terminated
CT.gov ID
NCT00182455
Collaborator
Janssen-Ortho Inc., Canada (Industry), Hamilton Health Sciences Corporation (Other)
12
Enrollment
1
Location
2
Arms
177
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2004
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Topiramate 25 - 400 mg/day x 12 weeks

Drug: Topiramate
25 - 400 mg/day x 12 weeks
Other Names:
  • Topomax

    		•
    Placebo Comparator: 2

    Placebo

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

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Global Impression - Improvement (CGI-I) ≤ 2 [12 weeks]

    2. Mean change in Liebowitz Social Anxiety Scale (LSAS) [12 weeks]

    Secondary Outcome Measures

    1. Social Phobia Scale [12 weeks]

    2. Social Phobia Inventory [12 weeks]

    3. Clinical Global Impression -Severity [12 weeks]

    4. Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale [12 weeks]

    5. Montgomery Asberg Depression Rating Scale [12 weeks]

    6. Beck Depression Inventory [12 weeks]

    7. Beck Anxiety Inventory [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MacAnxiety Research Centre Hamilton Ontario Canada L8S 1B7

    Sponsors and Collaborators

    • McMaster University
    • Janssen-Ortho Inc., Canada
    • Hamilton Health Sciences Corporation

    Investigators

    • Principal Investigator: Michael Van Ameringen, MD, FRCPC, Hamilton Health Sciences Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    McMaster University
    ClinicalTrials.gov Identifier:
    NCT00182455
    Other Study ID Numbers:
    • 04-080
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Sep 2, 2020
    Last Verified:
    Apr 1, 2018
    Keywords provided by McMaster University
    Treatment Refractory Generalized Social Phobia
    Additional relevant MeSH terms:
    Phobic Disorders
    Phobia, Social
    Topiramate

    Study Results

    No Results Posted as of Sep 2, 2020