Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD) - Full Text View

Sponsor:	McMaster University
Collaborator:	Janssen-Ortho Inc., Canada
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182520

Purpose

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.

Condition	Intervention	Phase
Obsessive Compulsive Disorder	Drug: Topiramate Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Serotonin Topiramate

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	48
Study Start Date:	January 2002
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Topiramate	Drug: Topiramate 25 mg - 400 mg/day x 12 weeks Other Name: Topomax
Placebo Comparator: 2 placebo	Drug: placebo 25 - 400 mg/day x 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182520

Contacts

Contact: Beth E Patterson, BScN, BEd

905-521-2100 ext 76181

bpatter@mcmaster.ca

Locations

Canada, Ontario
McMaster University Medical Centre	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Deidre L Henne, CA 905-521-2100 ext 74595 henne@hhsc.ca
Sub-Investigator: Catherine Mancini, MD, FRCPC
Sub-Investigator: Steve Collins, MB, FRCPC
Sub-Investigator: Jonathan Oakman, PhD
Principal Investigator: Michael Van Ameringen, MD, FRCPC

Sponsors and Collaborators

McMaster University

Janssen-Ortho Inc., Canada

Investigators

Principal Investigator:

Michael VanAmeringen, MD, FRCPC

Hamilton Health Sciences Corporation

More Information

No publications provided

Responsible Party:	Dr. Michael Van Ameringen, McMaster University/Hamilton Health Sciences
ClinicalTrials.gov Identifier:	NCT00182520 History of Changes
Other Study ID Numbers:	01-133
Study First Received:	September 14, 2005
Last Updated:	September 1, 2010
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

Treatment Refractory Obsessive Compulsive Disorder

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Topiramate
Serotonin Uptake Inhibitors
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on February 12, 2012