Status:
TERMINATED
Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Janssen-Ortho Inc., Canada
Hamilton Health Sciences Corporation
Conditions:
Social Phobia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00182455
Start Date
March 1 2004
End Date
December 1 2018
Last Update
September 2 2020
Active Locations (1)
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1
MacAnxiety Research Centre
Hamilton, Ontario, Canada, L8S 1B7