Actively Recruiting
Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression
Led by The Royal Ottawa Mental Health Centre · Updated on 2025-12-17
210
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary and competent to consent to study
- Adults aged 18 years old or older
- Can speak and read English
- Primary or predominant diagnosis of major depressive episode without psychotic features confirmed by Mini-International Neuropsychiatric Interview
- Depressive symptoms have not improved after at least one adequate antidepressant trial in current episode
- Moderate symptoms with score of at least 15 on Grid 17-item Hamilton Rating Scale for Depression
- Referred to rTMS treatment by treating physician and freely chose to follow treatment
- Able to adhere to treatment schedule
- Stable psychotropic medications or psychotherapy for at least four weeks before trial
- Education-adjusted Mini-Mental State Evaluation score of at least 24 if aged 65 or older
You will not qualify if you...
- Diagnosis of bipolar I or II disorder based on DSM-5 criteria
- Current or past (less than 3 months) substance or alcohol use disorder, except mild cannabis or alcohol use disorder in past 3 months
- Current use of illegal substances or cannabis (except medical use), confirmed by urine test
- Major unstable medical or neurologic illness such as uncontrolled diabetes or renal dysfunction
- Organic cause of depressive symptoms such as thyroid dysfunction
- Acute suicidality or life-threatening self-neglect
- Pregnant, breastfeeding, or planning pregnancy during treatment
- Contraindications for TMS, including history of epilepsy, seizure, metallic head implant, or pacemaker
- Unwilling to maintain current antidepressant regimen
- Taking more than 1 mg of lorazepam per day or equivalent
- Any condition that may affect ability to complete study as judged by investigators
- Contraindications for MRI
- Failed course of ECT in current depressive episode
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Royal's Institute of Mental Health Research
Ottawa, Ontario, Canada, K1Z 7K4
Actively Recruiting
Research Team
S
Stacey Shim, MSc
CONTACT
E
Emma Cummings, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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