Clincosm LogoSign in Get a demo

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

Sponsor
McMaster University (Other)
Overall Status
Completed
CT.gov ID
NCT00182520
Collaborator
Janssen-Ortho Inc., Canada (Industry), Hamilton Health Sciences Corporation (Other)
23
Enrollment
1
Location
2
Arms
204
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
23 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 :
Jan 1, 2002
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Topiramate

Drug: Topiramate
25 mg - 400 mg/day x 12 weeks
Other Names:
  • Topomax

    		•
    Placebo Comparator: 2

    placebo

    Drug: placebo
    25 - 400 mg/day x 12 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [12 weeks]

    2. Clinical Global Impression - Improvement ≤ 2 [12 weeks]

    Secondary Outcome Measures

    1. Montgomery Asberg Depression Rating Scale [12 weeks]

    2. Sheehan Disability Scale [12 weeks]

    3. Beck Depression Inventory [12 weeks]

    4. PI-SWUR Hoarding Scale [12 weeks]

    5. Self Report Y-BOCS [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    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

    Locations

    Site City State Country Postal Code
    1 MacAnxiety Research Centre Hamilton Ontario Canada L8S 1B7

    Sponsors and Collaborators

    • McMaster University
    • Janssen-Ortho Inc., Canada
    • Hamilton Health Sciences Corporation

    Investigators

    • Principal Investigator: Michael VanAmeringen, MD, FRCPC, McMaster University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    McMaster University
    ClinicalTrials.gov Identifier:
    NCT00182520
    Other Study ID Numbers:
    • 01-133
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Sep 1, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by McMaster University
    Treatment Refractory Obsessive Compulsive Disorder
    Additional relevant MeSH terms:
    Disease
    Compulsive Personality Disorder
    Obsessive-Compulsive Disorder
    Topiramate

    Study Results

    No Results Posted as of Sep 1, 2020