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

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ClinicalTrials.gov Identifier: NCT00182520
Recruitment Status : Recruiting
First Posted : September 16, 2005
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
Janssen-Ortho Inc., Canada
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University

Brief Summary:
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 or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: Topiramate Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : January 2002
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate
U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks ]
  2. Sheehan Disability Scale [ Time Frame: 12 weeks ]
  3. Beck Depression Inventory [ Time Frame: 12 weeks ]
  4. PI-SWUR Hoarding Scale [ Time Frame: 12 weeks ]
  5. Self Report Y-BOCS [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182520


Contacts
Contact: Beth E Patterson, BScN, BEd 905-921-7644 bpatter@mcmaster.ca

Locations
Canada, Ontario
MacAnxiety Research Centre Recruiting
Hamilton, Ontario, Canada, L8S 1B7
Contact: Beth Patterson, BScN, BEd    905-921-7644    bpatter@mcmaster.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
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Michael VanAmeringen, MD, FRCPC McMaster University

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT00182520     History of Changes
Other Study ID Numbers: 01-133
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: March 2017

Keywords provided by McMaster University:
Treatment Refractory Obsessive Compulsive Disorder

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Topiramate
Serotonin Uptake Inhibitors
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents