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Can Magnetic Brain Stimulation Help Prevent Relapse in Depression?

Primary Purpose

Major Depressive Disorder

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (rTMS)
Treatment as Usual
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Boniface Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cluster rTMS

Taper rTMS

Treatment as Usual

Arm Description

Two weeks of daily repetitive Transcranial Magnetic Stimulation (total of 10 rTMS sessions), six months following completion of regular six-week rTMS treatment.

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)

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

Outcomes

Primary Outcome Measures

Change in depressive symptom severity
Changes in depressive symptoms will be measured through administration of the Hamilton Depression (Ham-D) Scale.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2014
Last Updated
November 10, 2021
Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02029963
Brief Title
Can Magnetic Brain Stimulation Help Prevent Relapse in Depression?
Official Title
The Efficacy of Repetitive Transcranial Magnetic Stimulation in Relapse Prevention of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Unsuccessful in obtaining recruitment
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
November 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cluster rTMS
Arm Type
Experimental
Arm Description
Two weeks of daily repetitive Transcranial Magnetic Stimulation (total of 10 rTMS sessions), six months following completion of regular six-week rTMS treatment.
Arm Title
Taper rTMS
Arm Type
Experimental
Arm Description
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)
Arm Title
Treatment as Usual
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (rTMS)
Intervention Description
A non-invasive method for brain stimulation
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
An individually-tailored maintenance plan as determined by a psychiatrist or primary care provider
Primary Outcome Measure Information:
Title
Change in depressive symptom severity
Description
Changes in depressive symptoms will be measured through administration of the Hamilton Depression (Ham-D) Scale.
Time Frame
One year with bi-monthly measurements

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandana Modirrousta, MD PhD
Organizational Affiliation
Saint Boniface General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3P2B4
Country
Canada

12. IPD Sharing Statement

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Can Magnetic Brain Stimulation Help Prevent Relapse in Depression?

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