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

Study Overview
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Brief Summary
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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.

Official Title
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A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Drug: Topiramate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Topiramate | Drug: Topiramate<br>* 25 mg - 400 mg/day x 12 weeks<br>* Other names: Topomax;|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* 25 - 400 mg/day x 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) |  | 12 weeks | 
| Clinical Global Impression - Improvement ≤ 2 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale |  | 12 weeks | 
| Sheehan Disability Scale |  | 12 weeks | 
| Beck Depression Inventory |  | 12 weeks | 
| PI-SWUR Hoarding Scale |  | 12 weeks | 
| Self Report Y-BOCS |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Refractory Obsessive Compulsive Disorder