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

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by M. Van Ameringen, 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: December 12, 2016
Last verified: December 2016
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:


Further study details as provided by M. Van Ameringen, McMaster University:

Primary Outcome Measures:
  • Clinical Global Impression - Improvement (CGI-I) ≤ 2 [ Time Frame: 12 weeks ]
  • Mean change in Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Social Phobia Scale [ Time Frame: 12 weeks ]
  • Social Phobia Inventory [ Time Frame: 12 weeks ]
  • Clinical Global Impression -Severity [ Time Frame: 12 weeks ]
  • Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale [ Time Frame: 12 weeks ]
  • Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks ]
  • Beck Depression Inventory [ Time Frame: 12 weeks ]
  • Beck Anxiety Inventory [ Time Frame: 12 weeks ]

Estimated Enrollment: 48
Study Start Date: March 2004
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: December 12, 2016

Keywords provided by M. Van Ameringen, McMaster University:
Treatment Refractory Generalized Social Phobia

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Topiramate
Serotonin Uptake Inhibitors
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents

ClinicalTrials.gov processed this record on July 21, 2017