rTMS in Treatment Refractory Obsessive-Compulsive Disorder

June 14, 2019 updated by: McMaster University

A Randomized Crossed-over Trial Examining Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in Treatment Refractory Obsessive-Compulsive Disorder.

This study will evaluate the effectiveness of rTMS as a potential treatment for refractory OCD in a randomized, crossover design.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study is a minimum of 7 weeks long. In the first treatment phase (three weeks), participants will be randomly assigned to one of two treatment conditions: active rTMS or sham rTMS. The "sham" rTMS is the inactive form of the treatment where the experience during the sessions will be similar to an active rTMS session, but it will have no medical value. During these 3 weeks, they will attend a session each day for 5 days per week at Mood Disorders Clinic located at St. Joseph's Healthcare. Each of these sessions will be an hour long totalling 15 visits in the first 3 weeks. After every 5 sessions they will be asked to complete the following self-report questionnaires: Baratt Impulsiveness Scale, Hamilton Anxiety Rating Scale and the Hamilton Depression Rating Scale. The clinician-rated: Clinical Global Impression Scale and Yale Brown Obsessive Compulsive Scales will also be completed.

The two treatment phases will be separated by a flexible wash-out of a minimum of one week where participants will not attend any visits.

After this, they will begin the second treatment phase (three weeks) which will be the treatment condition they were not previously assigned to. In other words, individuals previously on the active rTMS treatment will now begin sham rTMS treatment and vice versa. These sessions will be identical to those involved in the first treatment phase, except the treatment condition will be different. Before and after each treatment session they will also be asked a series of questions to rate potential rTMS side effects and complete a cognitive task known as the "Go/no-go task."

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1B7
        • MacAnxiety Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a primary diagnosis of OCD (DSM 5) according to the MINI
  • Y-BOCS score of ≥20
  • History of treatment-resistant OCD, established by a trained psychiatrist with extensive expertise in the OCD field. Treatment-resistance will be defined as non-response to at least two SRIs trials (clomipramine, fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram).

Exclusion Criteria:

  • Any additional current psychiatric comorbidity, except for mild depressive and anxious symptoms
  • A lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition
  • Serious suicide risk
  • Episodic OCD
  • Illness duration less than two years
  • Hospitalization in the last 6 months
  • Pharmacological treatment changes in the last 3 months
  • The inability to receive rTMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives)
  • Any major medical disease
  • Pregnancy or nursing of an infant
  • The inability or refusal to provide informed consent
  • Prior TMS exposure (in order to reduce the risk of unblinding).

No psychotherapy and/or pharmacological treatment changes will be allowed during the study period. Pharmacologically treated patients should be on constant medications for at least 2 weeks before entering the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active rTMS
In rTMS, a device called a "stimulator" provides energy to a "magnetic coil". The coil is a handheld unit that delivers magnetic pulses. The coil is placed against the scalp on the top of your head. Sessions will occur once a day, 5 days/week, for 3 weeks.
Device: rTMS
Sham Comparator: Sham rTMS
The coil in the sham rTMS phase will be positioned 90 degrees off the scalp, with one wind of the coil touching the scalp. This will ensure that the participant will not be affected by the machine during this time. All other factors will be similar to the active rTMS phase.
Device: rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Yale Brown Obsessive Compulsive Scale
Time Frame: 7 Weeks
7 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Barratt Impulsiveness Scale
Time Frame: 7 Weeks
7 Weeks
Hamilton Anxiety rating Scale
Time Frame: 7 weeks
7 weeks
Hamilton Depression Rating Scale
Time Frame: 7 Weeks
7 Weeks
Clinical Global Impression Scale
Time Frame: 7 Weeks
7 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton
Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Michael Van Ameringen, MD, FRCPC, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 19, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0190

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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