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

Primary Purpose

Social Phobia

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Topiramate
Placebo
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia focused on measuring Treatment Refractory Generalized Social Phobia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • MacAnxiety Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Topiramate 25 - 400 mg/day x 12 weeks

Placebo

Outcomes

Primary Outcome Measures

Clinical Global Impression - Improvement (CGI-I) ≤ 2
Mean change in Liebowitz Social Anxiety Scale (LSAS)

Secondary Outcome Measures

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

Full Information

First Posted
September 14, 2005
Last Updated
August 31, 2020
Sponsor
McMaster University
Collaborators
Janssen-Ortho Inc., Canada, Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00182455
Brief Title
Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)
Official Title
Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
loss of funding
Study Start Date
March 1, 2004 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Janssen-Ortho Inc., Canada, Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
Treatment Refractory Generalized Social Phobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Topiramate 25 - 400 mg/day x 12 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topomax
Intervention Description
25 - 400 mg/day x 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
25 - 400 mg/day x 12 weeks
Primary Outcome Measure Information:
Title
Clinical Global Impression - Improvement (CGI-I) ≤ 2
Time Frame
12 weeks
Title
Mean change in Liebowitz Social Anxiety Scale (LSAS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Social Phobia Scale
Time Frame
12 weeks
Title
Social Phobia Inventory
Time Frame
12 weeks
Title
Clinical Global Impression -Severity
Time Frame
12 weeks
Title
Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale
Time Frame
12 weeks
Title
Montgomery Asberg Depression Rating Scale
Time Frame
12 weeks
Title
Beck Depression Inventory
Time Frame
12 weeks
Title
Beck Anxiety Inventory
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Van Ameringen, MD, FRCPC
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
MacAnxiety Research Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1B7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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