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Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)
This study is currently recruiting participants.
Verified by McMaster University, February 2009
First Received: September 14, 2005   Last Updated: February 12, 2009   History of Changes
Sponsors and Collaborators: McMaster University
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: 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

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 ] [ 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 2010
Estimated Primary Completion Date: December 2009 (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 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
  More Information

No publications provided

Responsible Party: McMaster University/Hamilton Health Sciences ( Dr. Michael Van Ameringen )
Study ID Numbers: 01-133
Study First Received: September 14, 2005
Last Updated: February 12, 2009
ClinicalTrials.gov Identifier: NCT00182520     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Treatment Refractory Obsessive Compulsive Disorder

Study placed in the following topic categories:
Anti-Obesity Agents
Neurotransmitter Agents
Anxiety Disorders
Mental Disorders
Topiramate
Neuroprotective Agents
Serotonin Uptake Inhibitors
Anticonvulsants
Serotonin
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Serotonin Agents
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Topiramate
Central Nervous System Agents
Obsessive-Compulsive Disorder
Anticonvulsants

ClinicalTrials.gov processed this record on July 06, 2009