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

NCT00182520 | Completed Phase 4

• 1 other identifier: 01-133
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Keywords

Treatment Refractory Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (2)

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  12 weeks

• Clinical Global Impression - Improvement ≤ 2

  12 weeks

Secondary Outcomes (5)

• Montgomery Asberg Depression Rating Scale

  12 weeks

• Sheehan Disability Scale

  12 weeks

• Beck Depression Inventory

  12 weeks

• PI-SWUR Hoarding Scale

  12 weeks

• Self Report Y-BOCS

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Topiramate

Drug: Topiramate

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Topiramate DRUG

25 mg - 400 mg/day x 12 weeks

Also known as: Topomax

1

placebo DRUG

25 - 400 mg/day x 12 weeks

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B7, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Michael VanAmeringen, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: January 1, 2002
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

CA (1)