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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 1, 2026 → Aug 1, 2027
See other at-risk trials from The Royal Ottawa Mental Health Centre

Record History

  1. Primary and study completion pushed from Aug 1, 2026 to Aug 1, 2027 Eligibility criteria expanded, about 19 words · Secondary endpoints: details revised at 1 of 1 entry · Site details revised Show 3 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  2. Study Identification, Study Statusv3
  3. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06528938
Lead Sponsor The Royal Ottawa Mental Health Centre
Collaborators: Université de Sherbrooke
Conditions Depression, Depressive Disorder, Major
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov