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

Phase 4

Completed

• Conditions: Obsessive Compulsive Disorder
• Interventions: Drug: placebo; Drug: Topiramate

• Registration Number: NCT00182520
• Lead Sponsor: McMaster University

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

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo
1	Topiramate	Topiramate

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	12 weeks
Clinical Global Impression - Improvement ≤ 2	12 weeks

Secondary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale	12 weeks
Beck Depression Inventory	12 weeks
Sheehan Disability Scale	12 weeks
PI-SWUR Hoarding Scale	12 weeks
Self Report Y-BOCS	12 weeks

Trial Locations

Locations (1)

MacAnxiety Research Centre; 🇨🇦 Hamilton, Ontario, Canada