Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression

What this study is about

Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS), a type of rTMS, is a very promising new treatment for major depression in adults and adolescents. However, very few studies have assessed the efficacy of accelerated, three times a day TBS in comparison with standard once a day TBS in adolescents. The study aims to explore further evidence in hopes to conduct a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of a functional magnetic resonance imaging (fMRI)-guided accelerated rTMS protocol vs. standard once/daily rTMS for treatment-resistant depression in adolescents.

Who can join (things the study team will check)

✅ You may be able to join if…

• Voluntary and competent to consent.
• Ages 16-19 years old.
• Can speak and read English.
• Primary and/or predominant diagnosis of major depressive episode without psychotic features in the current episode, confirmed by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
• Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant in the current depressive episode.
• Moderate symptoms in the current depressive episode, indexed by a score of at least 40 on the Children's Depression Rating Scale Revised for depression (CDRS-R).
• Are able to adhere to the treatment schedule.
• Have stable psychotropic medications and/or psychotherapy regimen for at least four weeks before participating in the trial.

🚫 You may not be able to join if…

• Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
• Current or past substance (< 3 months) (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the DSM-5 criteria. Based on DSM-5 criteria, mild cannabis or alcohol use would be allowed in the past 3 months, moderate to severe would be an exclusion.
• Current use of illegal substances or cannabis confirmed by urine screening test.
• Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction).
• Organic cause of depressive symptoms (e.g. thyroid dysfunction), ruled out by the treating physician.
• Acute suicidality or life-threatening due to self-neglect.
• Are pregnant or breastfeeding, or plan to become pregnant during treatment (pregnancy will be assessed by a urine test).
• Have a specific contraindication to TMS and/or MRI (e.g., personal history of epilepsy or seizures, metal head implant, pacemaker).
• Unwilling to maintain the current antidepressant regimen.
• Taking more than 1 mg/day of lorazepam or equivalent.
• Any other condition that, in the opinion of the investigators, would impair the participant's ability to complete the study.

Where this trial is running

• The Royal's Institute of Mental Health Research, Ottawa, Ontario, Canada

Who to contact

Stacey Shim, MSc · 613-722-6521 · stacey.shim@theroyal.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06528938.