NCT06528938Recruiting
Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression
Randomized Pilot Trial Comparing the Feasibility and Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treatment-Resistant Depression in Adolescents
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 14 Jun 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Diseases
- Depression
- NCT number
- NCT06528938
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 Aug 2024 to the primary completion date, 1 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction).
Other illness
- Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
- Have a specific contraindication to TMS and/or MRI (e.g., personal history of epilepsy or seizures, metal head implant, pacemaker).
- Any other condition that, in the opinion of the investigators, would impair the participant's ability to complete the study.
Other
- 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.
- 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).
- Unwilling to maintain the current antidepressant regimen.
- Taking more than 1 mg/day of lorazepam or equivalent.
Who the study is looking for
- 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.
Age in the registry: 16 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal's Institute of Mental Health Research Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.