Comparing two methods of brain stimulation for treating depression in adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the efficacy of accelerated intermittent theta burst stimulation (iTBS) versus standard once-a-day iTBS in adolescents diagnosed with major depressive disorder. The study will recruit 10 adolescents aged 16-19 who have treatment-resistant depression and will assess their symptoms through clinical evaluations and self-report questionnaires. Participants will undergo an MRI scan before receiving either treatment for a duration of 6 weeks, with the accelerated group receiving treatment three times a day for 2 weeks. The goal is to gather evidence to support larger-scale trials for this promising treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntary and competent to consent.
2. Ages 16-19 years old.
3. Can speak and read English.
4. 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).
5. Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant in the current depressive episode.
6. 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).
7. Are able to adhere to the treatment schedule.
8. Have stable psychotropic medications and/or psychotherapy regimen for at least four weeks before participating in the trial.

Exclusion Criteria:

1. Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
2. 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.
3. Current use of illegal substances or cannabis confirmed by urine screening test.
4. Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction).
5. Organic cause of depressive symptoms (e.g. thyroid dysfunction), ruled out by the treating physician.
6. Acute suicidality or life-threatening due to self-neglect.
7. Are pregnant or breastfeeding, or plan to become pregnant during treatment (pregnancy will be assessed by a urine test).
8. Have a specific contraindication to TMS and/or MRI (e.g., personal history of epilepsy or seizures, metal head implant, pacemaker).
9. Unwilling to maintain the current antidepressant regimen.
10. Taking more than 1 mg/day of lorazepam or equivalent.
11. Any other condition that, in the opinion of the investigators, would impair the participant's ability to complete the study.

Where it's running

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

Study contacts

• Principal investigator: Sara Tremblay, PhD — The Royal's Institute of Mental Health Research
• Study coordinator: Stacey Shim, MSc
• Email: stacey.shim@theroyal.ca
• Phone: 613-722-6521

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.