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

Study Overview
=================
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.

Official Title
-----------------
Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.

Conditions
-----------------
Social Phobia

Intervention / Treatment
-----------------
* Drug: Topiramate
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Topiramate 25 - 400 mg/day x 12 weeks | Drug: Topiramate<br>* 25 - 400 mg/day x 12 weeks<br>* Other names: Topomax;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* 25 - 400 mg/day x 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Improvement (CGI-I) ≤ 2 |  | 12 weeks | 
| Mean change in Liebowitz Social Anxiety Scale (LSAS) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Depression Inventory |  | 12 weeks | 
| Beck Anxiety Inventory |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Refractory Generalized Social Phobia