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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 Hamilton Health Sciences, June 2008

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

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




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