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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by McMaster University
Janssen-Ortho Inc., Canada
Information provided by (Responsible Party):
M. Van Ameringen, McMaster University Identifier:
First received: September 14, 2005
Last updated: March 21, 2017
Last verified: March 2017
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 12 weeks ]
  • Clinical Global Impression - Improvement ≤ 2 [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks ]
  • Sheehan Disability Scale [ Time Frame: 12 weeks ]
  • Beck Depression Inventory [ Time Frame: 12 weeks ]
  • PI-SWUR Hoarding Scale [ Time Frame: 12 weeks ]
  • Self Report Y-BOCS [ Time Frame: 12 weeks ]

Estimated Enrollment: 48
Study Start Date: January 2002
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Topiramate
25 mg - 400 mg/day x 12 weeks
Other Name: Topomax
Placebo Comparator: 2
Drug: placebo
25 - 400 mg/day x 12 weeks


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00182520

Contact: Beth E Patterson, BScN, BEd 905-921-7644

Canada, Ontario
MacAnxiety Research Centre Recruiting
Hamilton, Ontario, Canada, L8S 1B7
Contact: Beth Patterson, BScN, BEd    905-921-7644   
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 Corporation
Janssen-Ortho Inc., Canada
Principal Investigator: Michael VanAmeringen, MD, FRCPC McMaster University
  More Information

Responsible Party: M. Van Ameringen, Professor, Department of Psychiatry and Behavioural Neurosciences, McMaster University Identifier: NCT00182520     History of Changes
Other Study ID Numbers: 01-133
Study First Received: September 14, 2005
Last Updated: March 21, 2017

Keywords provided by McMaster University:
Treatment Refractory Obsessive Compulsive Disorder

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents processed this record on April 28, 2017