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OpenTrials
Completed

NCT Number: NCT00182520

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

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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topiramate

Drug

25 mg - 400 mg/day x 12 weeks

Other names: Topomax

Placebo

Drug

25 - 400 mg/day x 12 weeks

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: 12 weeks

  2. Clinical Global Impression - Improvement ≤ 2

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

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

Registry information

Official study title

A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder

Important dates

Study start
2002
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2005
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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