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

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

MedlinePlus related topics:

Obsessive-Compulsive Disorder

ChemIDplus related topics:

Topiramate Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Hamilton Health Sciences:

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:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Topiramate	Drug: Topiramate 25 mg - 400 mg/day x 12 weeks
2: Placebo Comparator 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	beth@macanxiety.com

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

Hamilton Health Sciences

Janssen-Ortho Inc., Canada

Investigators


Principal Investigator:	Michael VanAmeringen, MD, FRCPC	Hamilton Health Sciences

More Information

Responsible Party:	McMaster University/Hamilton Health Sciences ( Dr. Michael Van Ameringen )
Study ID Numbers:	01-133
First Received:	September 14, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00182520
Health Authority:	Canada: Health Canada

Keywords provided by Hamilton Health Sciences:

Treatment Refractory Obsessive Compulsive Disorder

Study placed in the following topic categories:

Anxiety Disorders

Mental Disorders

Topiramate

Serotonin

Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Anti-Obesity Agents

Pathologic Processes

Disease

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Agents

Protective Agents

Neuroprotective Agents

Anticonvulsants

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Hamilton Health Sciences Janssen-Ortho Inc., Canada
Information provided by:	Hamilton Health Sciences
ClinicalTrials.gov Identifier:	NCT00182520