Can Magnetic Brain Stimulation Help Prevent Relapse in Depression?

NCT02029963 | Terminated DMC

• 1 other identifier: B2013:178
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptom severity

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

  One year with bi-monthly measurements

Study Arms (3)

Cluster rTMS

EXPERIMENTAL

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)

Taper rTMS

EXPERIMENTAL

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)

Treatment as Usual

EXPERIMENTAL

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

Interventions

Transcranial Magnetic Stimulation (rTMS) DEVICE

A non-invasive method for brain stimulation

Cluster rTMS; Taper rTMS

Treatment as Usual BEHAVIORAL

An individually-tailored maintenance plan as determined by a psychiatrist or primary care provider

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Medical Service Foundation: collaborator

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R3P2B4, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation; Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy

Study Officials

• Mandana Modirrousta, MD PhD

  Saint Boniface General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: November 10, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-09

Locations

CA (1)