NCT06528938

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Royal Ottawa Mental Health Centre · Academic / Other
• Sex: All
• Age: 16 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Recently the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) has significantly improved for Treatment-Resistant Depression (TRD) in adults and promising evidence suggesting safety and efficacy of rTMS in adolescents. These youth studies currently use outdated stimulation protocols, with most of them using treatments on a once/daily schedule. Given the prevalence, morbidity, and mortality associated with depression in adolescents, and considering that over 40% of adolescents do not respond to medications, a randomized controlled trial (RCT) to establish the safety and efficacy of new rTMS protocols for difficult-to-treat depression in adolescents is desperately needed. This open-label randomized controlled trial will compare accelerated intermittent theta burst stimulation (iTBS) and standard once a day iTBS in adolescents with major depressive disorder (MDD). For this pilot trial, 10 adolescents (5 females, 5 males) with treatment-resistant depression will be recruited. Each participant will undergo a 30-40-minute magnetic resonance imaging (MRI) scan, after which they will receive iTBS applied to the left dorsolateral prefrontal cortex (DLPFC) once a day for 6 weeks (standard treatment) or for an accelerated duration of 3 times a day for 2 weeks. Symptoms will be assessed through clinical assessments as well as self-report questionnaires. Prior to treatment start each participant will complete the clinical assessments as well as the self-report questionnaires for a baseline measurement. The self-report measures will be completed every 5th treatment (total of 7 times including baseline). The clinical assessments will be completed after the 15th and 30th treatment, as well as 2-,4-, and 12-weeks post treatment course (total of 6 times including baseline). The main outcome of this trial is a clinical response rate which will be defined as a ≥ 50% reduction in depressive symptoms based off of the Children's Depression Rating Scale Revised for depression (CDRS-R). The secondary outcome of this trial is suicidal ideation which will be measured by the Beck Scale for Suicidal Ideation (BSS), as well as several other outcomes such as anxiety, sleep quality, physical activity and stress. The ultimate goal of this study is to provide initial evidence for conducting a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of an fMRI-guided accelerated rTMS protocol vs. standard once/daily rTMS for treatment-resistant depression in adolescents.

Conditions

• Depression
• Depressive Disorder, Major

Interventions

Type	Name	Description
DEVICE	Theta Burst Stimulation	Cool B70 coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-07-30
• Last updated: 2025-09-09

Locations

1 site across 1 country: Canada