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Neural Mechanisms of Intermittent Theta Burst Stimulation in the Core Depression Network

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 1, 2025 to Jan 3, 2027 Trial status: Recruiting to Active, Not Recruiting · Completion date: Jan 1, 2026 to Jan 3, 2027 · Site details revisedv6 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jan 1, 2026 to Jan 3, 2027
    • Site details revised
  2. Primary completion date: Jun 1, 2025 to Dec 1, 2025 Completion date: Jun 1, 2025 to Jan 1, 2026v5 Show 1 more changeShow less
    • Completion date: Jun 1, 2025 to Jan 1, 2026
  3. Re-verified, no change to tracked fieldsv4
  4. Primary and study completion dates: Mar 1, 2024 to Jun 1, 2025 Start date changed from estimate of Jun 1, 2022 to Apr 26, 2023 · Eligibility criteria expanded, about 44 words · Secondary endpoints: details revised at 4 of 4 entriesv3 Show 3 more changesShow less
    • Start date changed from estimate of Jun 1, 2022 to Apr 26, 2023
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: details revised at 4 of 4 entries

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 1, 2022 to Jun 1, 2022 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Mar 1, 2022 to Jun 1, 2022
    • Site details revised
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 (TMS) uses magnetic fields to modulate brain activity. A novel form of repetitive TMS (rTMS), intermittent theta burst stimulation (iTBS), has emerged as a promising new treatment for depression. This technique may be advantageous due to its very short duration and potentially stronger effect on brain activity in comparison with standard rTMS. However, the exact effect of iTBS on the activity of the brain in clinical populations remains poorly understood. This project aims to improve understanding of the mechanisms of action of iTBS by comparing its neuronal effect to sham treatment in 22 individuals with a diagnosis of major depressive episode, using positron emission tomography (PET) and magnetic resonance imaging (MRI) in a double-blind cross-over experiment, followed by a 6-week daily treatment course of iTBS.
Trial Details
NCT Number NCT05224206
Lead Sponsor The Royal Ottawa Mental Health Centre
Conditions Major Depressive Disorder
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov