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

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Topiramate
placebo
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Treatment Refractory Obsessive Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MacAnxiety Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Topiramate

placebo

Outcomes

Primary Outcome Measures

Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Clinical Global Impression - Improvement ≤ 2

Secondary Outcome Measures

Montgomery Asberg Depression Rating Scale
Sheehan Disability Scale
Beck Depression Inventory
PI-SWUR Hoarding Scale
Self Report Y-BOCS

Full Information

First Posted
September 14, 2005
Last Updated
August 31, 2020
Sponsor
McMaster University
Collaborators
Janssen-Ortho Inc., Canada, Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00182520
Brief Title
Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)
Official Title
A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Janssen-Ortho Inc., Canada, Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Treatment Refractory Obsessive Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Topiramate
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topomax
Intervention Description
25 mg - 400 mg/day x 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
25 - 400 mg/day x 12 weeks
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame
12 weeks
Title
Clinical Global Impression - Improvement ≤ 2
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale
Time Frame
12 weeks
Title
Sheehan Disability Scale
Time Frame
12 weeks
Title
Beck Depression Inventory
Time Frame
12 weeks
Title
PI-SWUR Hoarding Scale
Time Frame
12 weeks
Title
Self Report Y-BOCS
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael VanAmeringen, MD, FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MacAnxiety Research Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1B7
Country
Canada

12. IPD Sharing Statement

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

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