Actively Recruiting
Neural Mechanisms of Intermittent Theta Burst Stimulation in the Core Depression Network
Led by The Royal Ottawa Mental Health Centre · Updated on 2025-09-09
22
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Repetitive Transcranial magnetic stimulation (TMS) uses magnetic fields to modulate brain activity. A novel form of repetitive TMS (rTMS), intermittent theta burst stimulation (iTBS), has emerged as a promising new treatment for depression. This technique may be advantageous due to its very short duration and potentially stronger effect on brain activity in comparison with standard rTMS. However, the exact effect of iTBS on the activity of the brain in clinical populations remains poorly understood. This project aims to improve understanding of the mechanisms of action of iTBS by comparing its neuronal effect to sham treatment in 22 individuals with a diagnosis of major depressive episode, using positron emission tomography (PET) and magnetic resonance imaging (MRI) in a double-blind cross-over experiment, followed by a 6-week daily treatment course of iTBS.
CONDITIONS
Official Title
Neural Mechanisms of Intermittent Theta Burst Stimulation in the Core Depression Network
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 55 years of age
- Diagnosis of major depressive disorder (MDD) confirmed by Mini-International Neuropsychiatric Interview
- Symptoms of MDD not improved after 1 to 7 adequate antidepressant trials in current episode
- Baseline score of 15 or higher on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
- Stable antidepressant treatment for at least four weeks before joining the trial
- Voluntary and competent to give consent
- Able to speak and read English
You will not qualify if you...
- Current or recent (less than 3 months) substance or alcohol abuse, including nicotine
- Positive urine test for illegal drugs, cannabis, or cotinine
- Suicide attempt in the past three months or active suicidal intent
- Pregnancy or breastfeeding
- Psychotic symptoms during current depressive episode
- Other mental health disorders except anxiety, panic disorders, or ADHD
- Significant unstable medical or neurological illness
- Organic causes for depressive symptoms ruled out by physician
- Contraindications for TMS (e.g., epilepsy, metallic head implants, pacemaker)
- Contraindications for MRI (e.g., metallic implants, claustrophobia)
- Prior participation in PET or SPECT research studies
- Electroconvulsive therapy (ECT) or rTMS treatment during current episode
- Use of benzodiazepines
- Body mass index (BMI) higher than 35 or lower than 18
- Any other condition that could affect ability to complete the study as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada, K1Z 7K4
Actively Recruiting
Research Team
S
Stacey Shim, MSc
CONTACT
J
Jessica Drodge, MSc
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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