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

This study is currently recruiting participants.

Verified March 2013 by McMaster University

Sponsor:

Collaborator:

Janssen-Ortho Inc., Canada

Information provided by (Responsible Party):

M. Van Ameringen, McMaster University

ClinicalTrials.gov Identifier:

NCT00182520

First received: September 14, 2005

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

March 4, 2013

Start Date ^ICMJE

January 2002

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Clinical Global Impression - Improvement ≤ 2

Change History

Complete list of historical versions of study NCT00182520 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Montgomery Asberg Depression Rating Scale
Sheehan Disability Scale
Beck Depression Inventory
PI-SWUR Hoarding Scale
Self Report Y-BOCS

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Obsessive Compulsive Disorder

Intervention ^ICMJE

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

Other Name: Topomax
Drug: placebo
25 - 400 mg/day x 12 weeks

Study Arm (s)

Experimental: 1
Topiramate

Intervention: Drug: Topiramate
Placebo Comparator: 2
placebo

Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2015

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact: Beth E Patterson, BScN, BEd

905-921-7644

bpatter@mcmaster.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00182520

Other Study ID Numbers ^ICMJE

01-133

Has Data Monitoring Committee

Responsible Party

M. Van Ameringen, McMaster University

Study Sponsor ^ICMJE

Hamilton Health Sciences Corporation

Collaborators ^ICMJE

Janssen-Ortho Inc., Canada

Investigators ^ICMJE

Principal Investigator:

Michael VanAmeringen, MD, FRCPC

McMaster University

Information Provided By

McMaster University

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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