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

Obsessive Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182520
• Other study ID #: 01-133
• Status: Completed
• Phase: Phase 4
• Start date: January 2002
• Est. completion date: January 2019

Study information

• Verified date: August 2020
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• Topiramate
25 mg - 400 mg/day x 12 weeks
• placebo
25 - 400 mg/day x 12 weeks

Locations

Country	Name	City	State
Canada	MacAnxiety Research Centre	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation, Janssen-Ortho Inc., Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale (Y-BOCS)		12 weeks
Primary	Clinical Global Impression - Improvement = 2		12 weeks
Secondary	Montgomery Asberg Depression Rating Scale		12 weeks
Secondary	Sheehan Disability Scale		12 weeks
Secondary	Beck Depression Inventory		12 weeks
Secondary	PI-SWUR Hoarding Scale		12 weeks
Secondary	Self Report Y-BOCS		12 weeks