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 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

September 14, 2005
March 4, 2013
March 2004
October 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • Clinical Global Impression - Improvement (CGI-I) ≤ 2
  • Mean change in Liebowitz Social Anxiety Scale (LSAS)
Complete list of historical versions of study NCT00182455 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Mean change from baseline in the following measures:
  • Social Phobia Scale
  • Social Phobia Ineventory
  • Clinical Global Impression -Severity
  • Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale
  • Montgomery Asberg Depression Rating Scale
  • Beck Depression Ineventory
  • Beck Anxiety Inventory
Not Provided
Not Provided
 
Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)
Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Social Phobia
  • Drug: Topiramate
    25 - 400 mg/day x 12 weeks
    Other Name: Topomax
  • Drug: Placebo
    25 - 400 mg/day x 12 weeks
  • Experimental: 1
    Topiramate 25 - 400 mg/day x 12 weeks
    Intervention: Drug: Topiramate
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
December 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Beth Patterson, BScN, BEd 905-921-7644 bpatter@mcmaster.ca
Canada
 
NCT00182455
04-080
No
M. Van Ameringen, McMaster University
Hamilton Health Sciences Corporation
Janssen-Ortho Inc., Canada
Principal Investigator: Michael Van Ameringen, MD, FRCPC Hamilton Health Sciences Corporation
McMaster University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP