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

This study is currently recruiting participants.
Verified March 2013 by McMaster University
Sponsor:
Collaborator:
Janssen-Ortho Inc., Canada
Information provided by (Responsible Party):
M. Van Ameringen, McMaster University
ClinicalTrials.gov Identifier:
NCT00182455
First received: September 14, 2005
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Social Phobia
 Drug: Topiramate
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Phobias
U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Clinical Global Impression - Improvement (CGI-I) ≤ 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change in Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social Phobia Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Social Phobia Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression -Severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: March 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Topiramate 25 - 400 mg/day x 12 weeks
 Drug: Topiramate
25 - 400 mg/day x 12 weeks
Other Name: Topomax
Placebo Comparator: 2
Placebo
 Drug: Placebo
25 - 400 mg/day x 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182455

Contacts
Contact: Beth Patterson, BScN, BEd 905-921-7644 bpatter@mcmaster.ca

Locations
Canada, Ontario
MacAnxiety Research Centre Recruiting
Hamilton, Ontario, Canada, L8S 1B7
Contact: Beth Patterson, BScN, BEd     905-921-7644     bpatter@mcmaster.ca    
Principal Investigator: Michael Van Ameringen, MD, FRCPC            
Sub-Investigator: Steve Collins, MBChB, FRCPC            
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Janssen-Ortho Inc., Canada
Investigators
Principal Investigator: Michael Van Ameringen, MD, FRCPC Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: M. Van Ameringen, Professor, Department of Psychiatry and Behavioural Neurosciences, McMaster University
ClinicalTrials.gov Identifier: NCT00182455     History of Changes
Other Study ID Numbers: 04-080
Study First Received: September 14, 2005
Last Updated: March 4, 2013
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Treatment Refractory Generalized Social Phobia

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Topiramate
Serotonin Uptake Inhibitors
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on May 16, 2013