Can Magnetic Brain Stimulation Help Prevent Relapse in Depression?

November 10, 2021 updated by: University of Manitoba

The Efficacy of Repetitive Transcranial Magnetic Stimulation in Relapse Prevention of Major Depressive Disorder

The purpose of this study is to investigate the use of repetitive transcranial magnetic stimulation (rTMS) in helping to prevent relapse in major depressive disorder. rTMS is known to be an effective treatment for major depressive disorder, but there is also evidence that it may be effective in the maintenance of remission following treatment. However, it is not yet clear what maintenance strategy will yield the best outcome in preventing relapse.

In this study, eligible patients who have finished one full course of rTMS for treatment of major depression will be randomized into three groups: (i) cluster rTMS, (ii) taper rTMS, and (iii) treatment as usual. The 'cluster rTMS' group will receive two weeks to daily rTMS six months after the completion of their regular rTMS treatment, the 'taper rTMS' group will receive three sessions a week for two weeks followed by two sessions a week for two weeks immediately following their regular rTMS treatment, while the 'treatment as usual' group will receive standard follow-up care from their own psychiatrist and/or primary care doctor.

The investigators hypothesize that the group with cluster treatment will show significantly lower relapse rates in depressive symptoms as compared to the other groups.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to investigate the efficacy of rTMS to the dorsolateral prefrontal cortex (dlPFC) as a maintenance therapy following standard rTMS treatment in major depressive disorder.

A total of 45 patients will be recruited for this study. Patients who have completed a standard six-week rTMS treatment for major depressive disorder will be randomly assigned to one of the three groups: cluster rTMS, taper rTMS, and treatment as usual. Patients in the 'cluster' group will receive two weeks of daily rTMS (10 rTMS sessions) six months after completing their rTMS treatment. Patients in the 'taper' group will receive rTMS immediately after completing rTMS treatment and the frequency of the sessions will be tapered as follows: three sessions a week for two weeks, and then two sessions a week for two weeks. The maintenance plan for patients in 'treatment as usual' group will be decided individually and may include any or all of the following: continue or start on medication, start psychotherapy and/or follow-up visits with psychiatrist or primary care provider.

Each session of rTMS will be identical: lasting about one hour and consisting of 3000 high frequency (10 Hz) pulses. After finishing their last session of rTMS treatment, all patients will be seen by the rTMS psychiatrists bi-monthly for one year. Each visit will last approximately half an hour during which time the Hamilton Depression (Ham-D) Scale will be administered.

Given the high relapse rates following rTMS treatment for depression, the investigators hope that results from this study will be very helpful to patients suffering from major depressive disorder in improving their quality of life by reducing their rate of relapse.

Study Type

Interventional

Enrollment (Actual)

21

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
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3P2B4
        • St. Boniface Hospital

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Major Depressive Disorder
  • Patients who are not actively receiving any psychotherapy
  • Patients who are on no or only one antidepressant

Exclusion Criteria:

  • History of a psychotic episode
  • History of neurological illness
  • Previous head injury
  • Active alcohol or substance abuse
  • History of seizure disorders
  • Currently pregnant

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cluster rTMS
Two weeks of daily repetitive Transcranial Magnetic Stimulation (total of 10 rTMS sessions), six months following completion of regular six-week rTMS treatment.
Device: Transcranial Magnetic Stimulation (rTMS)
A non-invasive method for brain stimulation
Experimental: Taper rTMS
Immediately following completion of regular six-week repetitive Transcranial Magnetic Stimulation treatment, patients in this group will receive three sessions of rTMS a week for two weeks followed by two sessions of rTMS a week for two weeks (total of 10 rTMS sessions tapered in 4 weeks)
Device: Transcranial Magnetic Stimulation (rTMS)
A non-invasive method for brain stimulation
Experimental: Treatment as Usual
Following their last session of regular six-week rTMS treatment, patients in this group will follow an individually-tailored maintenance plan as determined by their own psychiatrist or primary care provider
Behavioral: Treatment as Usual
An individually-tailored maintenance plan as determined by a psychiatrist or primary care provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptom severity
Time Frame: One year with bi-monthly measurements
Changes in depressive symptoms will be measured through administration of the Hamilton Depression (Ham-D) Scale.
One year with bi-monthly measurements

Collaborators and Investigators

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

Sponsor

University of Manitoba

Collaborators

Manitoba Medical Service Foundation

Investigators

  • Principal Investigator: Mandana Modirrousta, MD PhD, Saint Boniface General Hospital

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

February 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

November 10, 2021

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2013:178

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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