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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-01

Study Completion Date

2018-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Social Phobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Topiramate 25 - 400 mg/day x 12 weeks

Group Type EXPERIMENTAL

Topiramate

Intervention Type DRUG

25 - 400 mg/day x 12 weeks

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

25 - 400 mg/day x 12 weeks

Interventions

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Topiramate

25 - 400 mg/day x 12 weeks

Intervention Type DRUG

Placebo

25 - 400 mg/day x 12 weeks

Intervention Type DRUG

Other Intervention Names

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Topomax

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No