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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00182455

Enrollment

Registered

2005-09-16

Start date

2004-03-01

Completion date

2018-12-01

Last updated

2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Phobia

Keywords

Treatment Refractory Generalized Social Phobia

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.

Interventions

DRUGTopiramate

25 - 400 mg/day x 12 weeks

DRUGPlacebo

25 - 400 mg/day x 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Clinical Global Impression -Severity	12 weeks
Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale	12 weeks
Social Phobia Scale	12 weeks
Beck Depression Inventory	12 weeks
Beck Anxiety Inventory	12 weeks
Montgomery Asberg Depression Rating Scale	12 weeks
Social Phobia Inventory	12 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026