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

NCT00182455 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-09-02

No results posted yet for this study

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

Interventions

DRUG

Topiramate

25 - 400 mg/day x 12 weeks

DRUG

Placebo

25 - 400 mg/day x 12 weeks

Sponsors & Collaborators

  • Janssen-Ortho Inc., Canada

    collaborator INDUSTRY

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • Michael Van Ameringen, MD, FRCPC · Hamilton Health Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-01
Primary Completion
2018-12-01
Completion
2018-12-01

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00182455 on ClinicalTrials.gov