RecruitingNot ApplicableNCT04142996

Comparing Uni- and Bi-lateral TBS in Major Depression

A Naturalistic Study Comparing Uni- and Bi-lateral Theta Burst Stimulation in Major Depression


Sponsor

The Royal Ottawa Mental Health Centre

Enrollment

256 participants

Start Date

Dec 12, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS) is a very promising new treatment for major depression that allows a 15-fold reduction in duration of daily sessions. However, no large scale naturalistic study has assessed the superiority of bilateral TBS in comparison with unilateral left TBS. In fact, no TBS study thus far has included both unipolar and bipolar depression, or other psychiatric comorbidities such as anxiety. Maintenance has yet to be studied with TBS, along with an effective maintenance protocol to prevent relapse. Our study aims to explore and address these gaps.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing one-sided versus two-sided brain stimulation using a technique called TBS (theta burst stimulation — a rapid type of rTMS/magnetic brain stimulation) for people with major depression who have not responded to antidepressant medication. **You may be eligible if...** - You are 18 or older and can speak and read English or French - You have been diagnosed with a major depressive episode without psychotic features - You have not improved after at least one adequate course of antidepressant medication in your current depressive episode - Your depression symptoms are moderate to severe (Hamilton Rating Scale score of at least 15) - Your doctor has referred you for rTMS treatment - Your psychiatric medication (if any) has been stable for at least 4 weeks **You may NOT be eligible if...** - You have epilepsy, a metal implant in the head, or a pacemaker (contraindications to TMS) - You have a serious unstable medical or neurological illness - You are pregnant or breastfeeding, or planning to become pregnant during the trial - You have recently failed electroconvulsive therapy (ECT) in the current episode - You are acutely suicidal - You are currently using illegal substances or more than 1 mg of lorazepam (or equivalent) daily Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETheta burst stimulation

Cool B70 coil (left DLPFC) and Cool B65 active/placebo coil (right DLPFC), with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)


Locations(1)

The Royal Ottawa Mental Health Centre

Ottawa, Ontario, Canada

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NCT04142996


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