Status:
COMPLETED
Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Janssen-Ortho Inc., Canada
Hamilton Health Sciences Corporation
Conditions:
Obsessive Compulsive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00182520
Start Date
January 1 2002
End Date
January 1 2019
Last Update
September 1 2020
Active Locations (1)
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1
MacAnxiety Research Centre
Hamilton, Ontario, Canada, L8S 1B7