Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)
- Registration Number
- NCT00182455
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Topiramate Topiramate 25 - 400 mg/day x 12 weeks 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method Clinical Global Impression - Improvement (CGI-I) ≤ 2 12 weeks Mean change in Liebowitz Social Anxiety Scale (LSAS) 12 weeks
- Secondary Outcome Measures
Name Time Method Beck Depression Inventory 12 weeks Social Phobia Scale 12 weeks Social Phobia Inventory 12 weeks Clinical Global Impression -Severity 12 weeks Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale 12 weeks Montgomery Asberg Depression Rating Scale 12 weeks Beck Anxiety Inventory 12 weeks
Trial Locations
- Locations (1)
MacAnxiety Research Centre
🇨🇦Hamilton, Ontario, Canada