Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)

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:
NCT00182520
First received: September 14, 2005
Last updated: March 4, 2013
Last verified: March 2013

September 14, 2005
March 4, 2013
January 2002
December 2014   (final data collection date for primary outcome measure)
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression - Improvement ≤ 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
  • Clinical Global Impression - Improvement ≤ 2
Complete list of historical versions of study NCT00182520 on ClinicalTrials.gov Archive Site
  • Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • PI-SWUR Hoarding Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Self Report Y-BOCS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Montgomery Asberg Depression Rating Scale
  • Sheehan Disability Scale
  • Beck Depression Inventory
  • PI-SWUR Hoarding Scale
  • Self Report Y-BOCS
Not Provided
Not Provided
 
Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)
A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder

SRI's are considered first-line treatments for OCD, however many patients continue to have significant symptoms despite an adequate trial of an SRI. Neuroimaging studies have shown that the glutamate neurological system is involved in OCD. This study will test the safety and efficacy of topiramate, a drug, which targets glutamate, in the treatment of OCD, where the OCD has been un-responsive, or partially responsive to regular SRI treatment.

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
Obsessive Compulsive Disorder
  • Drug: Topiramate
    25 mg - 400 mg/day x 12 weeks
    Other Name: Topomax
  • Drug: placebo
    25 - 400 mg/day x 12 weeks
  • Experimental: 1
    Topiramate
    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
February 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Outpatient with primary DSM- IV OCD
  • Completion of a 14-week open label trial of one the following SRI's: fluoxetine 80 mg/day, paroxetine 60 mg/day, fluvoxamine 300 mg/day, clomipramine 250 mg/day, sertraline 200 mg/day, citalopram 60 mg/day, escitalopram 30 mg/day and demonstrating a non or partial responses to SRI treatment (CGI-I of 3 or 4, Y-BOCS reduction of < 35%)
  • Stable (8 wks or longer) concurrent medications including benzodiazepines, sedative hypnotics, antipsychotics, and antidepressants.

Exclusion Criteria:

  • Any other primary DSM-IV diagnosis; DSM-IV criteria for body dysmorphic disorder, bipolar affective disorder, schizophrenia, psychotic disorder, current alcohol/substance abuse.
  • A previous adequate trial of topiramate
  • Comorbid major depressive disorder diagnosis which predates OCD diagnosis
  • Cognitive behavioural therapy or additional psychotherapy in past four months
  • Allergy or hypersensitivity to topiramate
  • BMI < 20
  • History of kidney stones
Both
18 Years to 65 Years
No
Contact: Beth E Patterson, BScN, BEd 905-921-7644 bpatter@mcmaster.ca
Canada
 
NCT00182520
01-133
No
M. Van Ameringen, McMaster University
Hamilton Health Sciences Corporation
Janssen-Ortho Inc., Canada
Principal Investigator: Michael VanAmeringen, MD, FRCPC McMaster University
McMaster University
March 2013

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