RecruitingNot ApplicableNCT06152705

Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression

Triple-blind Randomized Trial Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression


Sponsor

The Royal Ottawa Mental Health Centre

Enrollment

210 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In this triple-blind randomized controlled trial, we ask if targeting intermittent theta burst stimulation (iTBS) based on individual resting state connectivity improves treatment outcomes in major depressive disorder (MDD). For the trial, we will recruit 210 patients with major depressive disorder. Each patient will undergo a 30-40-minute MRI scan, after which they will receive a 6-week standard iTBS treatment. Participants will be randomized to receive iTBS either to the standard neuronavigated target (a technique for treatment location targeting, based on group-average connectivity) or to a personalized connectivity-guided target selected based on individual functional connectivity scans. The main outcome of this trial is response rate as determined by ≥ 50% reduction in Grid HRSD-17 scores. Secondary outcomes include remission rate, change in depression, anxiety and anhedonia symptoms, quality of life, and biological measures of heart rate variability, objective sleep measures and daily activity as a proxy of anhedonia - defined as a reduced ability to experience pleasure.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of transcranial magnetic stimulation (TMS) for treating depression: standard TMS (which targets a fixed brain area) versus fMRI-guided TMS (which uses brain scan data to personalize where the stimulation is directed). The goal is to see if a more personalized approach improves outcomes for people with major depressive disorder (MDD) who haven't responded to antidepressants. **You may be eligible if...** - You are 18 years or older and can speak and read English - You have been diagnosed with major depressive disorder without psychotic features in your current episode - You have not adequately responded to at least one antidepressant medication in the current episode - Your depression is moderate or severe (score ≥ 15 on the Hamilton Rating Scale) - Your doctor has referred you for TMS treatment - Your psychiatric medications have been stable for at least 4 weeks **You may NOT be eligible if...** - You have bipolar I or II disorder - You have a history of psychosis, epilepsy, or a metallic head implant or pacemaker - You currently use illegal drugs (other than medically prescribed cannabis) - You are pregnant or breastfeeding - You are acutely suicidal - You have a serious, unstable medical or neurological illness - You have previously failed electroconvulsive therapy (ECT) in the current episode 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

DEVICErepetitive Transcranial Magnetic Stimulation

Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Typical treatments involve 30 to 45 minutes daily sessions delivered over 4 to 6 weeks. Recent technical advances allowed the development of theta burst stimulation (TBS), a novel rTMS paradigm that reduces daily sessions to 3 to 4 minutes while maintaining the same clinical efficacy. This study will specifically be administering intermittent TBS (iTBS), which is a novel refinement of conventional rTMS and consists of bursts of 3 stimulations at 50 Hz at theta frequency (5 Hz).


Locations(1)

The Royal's Institute of Mental Health Research

Ottawa, Ontario, Canada

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NCT06152705


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