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Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study Identification, Study Status, Oversightv4
  2. Notable Start date changed from estimate of Jun 10, 2024 to Sep 16, 2024v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Jan 1, 2024 to Jun 10, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Jan 1, 2024 to Jun 10, 2024
    • Site details revised
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In this triple-blind randomized controlled trial, we ask if targeting intermittent theta burst stimulation (iTBS) based on individual resting state connectivity improves treatment outcomes in major depressive disorder (MDD). For the trial, we will recruit 210 patients with major depressive disorder. Each patient will undergo a 30-40-minute MRI scan, after which they will receive a 6-week standard iTBS treatment. Participants will be randomized to receive iTBS either to the standard neuronavigated target (a technique for treatment location targeting, based on group-average connectivity) or to a personalized connectivity-guided target selected based on individual functional connectivity scans. The main outcome of this trial is response rate as determined by ≥ 50% reduction in Grid HRSD-17 scores. Secondary outcomes include remission rate, change in depression, anxiety and anhedonia symptoms, quality of life, and biological measures of heart rate variability, objective sleep measures and daily activity as a proxy of anhedonia - defined as a reduced ability to experience pleasure.
Trial Details
NCT Number NCT06152705
Lead Sponsor The Royal Ottawa Mental Health Centre
Conditions Depression, Depressive Disorder, Major, Depressive Episode
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov