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

NCT00182455 | Terminated Phase 4

• 1 other identifier: 04-080
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Phobia

Keywords

Treatment Refractory Generalized Social Phobia

Outcome Measures

Primary Outcomes (2)

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

  12 weeks

• Mean change in Liebowitz Social Anxiety Scale (LSAS)

  12 weeks

Secondary Outcomes (7)

• 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

Study Arms (2)

1

EXPERIMENTAL

Topiramate 25 - 400 mg/day x 12 weeks

Drug: Topiramate

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Topiramate DRUG

25 - 400 mg/day x 12 weeks

Also known as: Topomax

1

Placebo DRUG

25 - 400 mg/day x 12 weeks

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Janssen-Ortho Inc., Canada: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B7, Canada

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Michael Van Ameringen, MD, FRCPC

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2004
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 2, 2020

Record last verified: 2018-04

Locations

CA (1)