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

McMaster University

Status and phase: Terminated; Phase 4

Conditions: Social Phobia

Treatments: Drug: Placebo; Drug: Topiramate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00182455

04-080

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

12 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Topiramate 25 - 400 mg/day x 12 weeks

Treatment:

Drug: Topiramate

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo