Can Magnetic Brain Stimulation Help Prevent Relapse in Depression?
NCT ID: NCT02029963
Last Updated: 2021-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
21 participants
INTERVENTIONAL
2014-02-28
2021-11-10
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Transcranial Magnetic Stimulation (rTMS)
A non-invasive method for brain stimulation
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)
Transcranial Magnetic Stimulation (rTMS)
A non-invasive method for brain stimulation
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
Treatment as Usual
An individually-tailored maintenance plan as determined by a psychiatrist or primary care provider
Interventions
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Transcranial Magnetic Stimulation (rTMS)
A non-invasive method for brain stimulation
Treatment as Usual
An individually-tailored maintenance plan as determined by a psychiatrist or primary care provider
Eligibility Criteria
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Inclusion Criteria
* Patients who are not actively receiving any psychotherapy
* Patients who are on no or only one antidepressant
Exclusion Criteria
* History of neurological illness
* Previous head injury
* Active alcohol or substance abuse
* History of seizure disorders
* Currently pregnant
18 Years
85 Years
ALL
No
Sponsors
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Manitoba Medical Service Foundation
OTHER
University of Manitoba
OTHER
Responsible Party
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Principal Investigators
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Mandana Modirrousta, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Saint Boniface General Hospital
Locations
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St. Boniface Hospital
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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B2013:178
Identifier Type: -
Identifier Source: org_study_id