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

This study is currently recruiting participants.
Study NCT00182520.   Last updated on June 27, 2008.   Information provided by McMaster University

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Descriptive Information Fields
Brief Title  Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)
Official Title  A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder
Brief Summary

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.

Detailed Description
Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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 ]
Secondary Outcome Measure  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 ]
Condition  Obsessive Compulsive Disorder
Intervention  Drug: Topiramate
Drug: placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  48
Start Date  January 2002
Completion Date June 2008
Eligibility Criteria 

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
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Beth E Patterson, BScN, BEd     905-521-2100 ext 76181     beth@macanxiety.com    
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00182520
Organization ID 01-133
Secondary IDs ††
Study Sponsor  Hamilton Health Sciences
Collaborators †† Janssen-Ortho Inc., Canada
Investigators 
Principal Investigator:     Michael VanAmeringen, MD, FRCPC     Hamilton Health Sciences    
Information Provided By McMaster University
Verification Date June 2008
First Received Date  September 14, 2005
Last Updated Date June 27, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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