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

Phase 4TerminatedNCT00182455

McMaster University12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Social Phobia

Interventions

TopiramateDRUG

25 - 400 mg/day x 12 weeks

PlaceboDRUG

25 - 400 mg/day x 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

MacAnxiety Research Centre

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Clinical Global Impression - Improvement (CGI-I) ≤ 2

Time frame: 12 weeks

Mean change in Liebowitz Social Anxiety Scale (LSAS)

Time frame: 12 weeks

Secondary Outcomes

Social Phobia Scale

Time frame: 12 weeks

Social Phobia Inventory

Time frame: 12 weeks

Clinical Global Impression -Severity

Time frame: 12 weeks

Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale

Time frame: 12 weeks

Montgomery Asberg Depression Rating Scale

Time frame: 12 weeks

Beck Depression Inventory

Time frame: 12 weeks

Beck Anxiety Inventory

Time frame: 12 weeks

Data from ClinicalTrials.gov

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