Clinical trial NCT00182455: Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)
Official title: Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Social Phobia
Keywords: Treatment Refractory Generalized Social Phobia
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Janssen-Ortho Inc., Canada
name: Hamilton Health Sciences Corporation
First posted: 2005-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impression - Improvement (CGI-I) ≤ 2
timeFrame: 12 weeks
measure: Mean change in Liebowitz Social Anxiety Scale (LSAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Social Phobia Scale
timeFrame: 12 weeks
measure: Social Phobia Inventory
timeFrame: 12 weeks
measure: Clinical Global Impression -Severity
timeFrame: 12 weeks
measure: Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale
timeFrame: 12 weeks
measure: Montgomery Asberg Depression Rating Scale
timeFrame: 12 weeks
measure: Beck Depression Inventory
timeFrame: 12 weeks
measure: Beck Anxiety Inventory
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: MacAnxiety Research Centre
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Michael Van Ameringen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: