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Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Dec 15, 2025 to Mar 1, 2026 Eligibility criteria expanded, about 22 words · Secondary endpoints: details revised at 6 of 7 entries · Study description revised Show 3 more changesShow less
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 6 of 7 entries
    • Study description revised
  2. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 30, 2025 to Dec 15, 2025 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Sep 30, 2025 to Dec 15, 2025
    • Site details revised
  3. Start date: Jan 31, 2025 to Sep 30, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this study is to collect feasibility data on combining structured exercise aimed to improve physical fitness, and intermittent TBS (iTBS) in treating individuals diagnosed with difficult-to-treat depression who are physically inactive. By conducting this trial, we will compare the therapeutic benefits of the combined approach against the standard treatment of iTBS alone (without exercise). These findings will be used to inform future large-scale projects in which we will investigate, in a larger sample size, whether structured exercise aimed to improve fitness as recommended by most public exercise guidelines (i.e., ≥3x/week, moderate-to-vigorous intensity) serves as an active ingredient that amplifies the effectiveness of iTBS. Ultimately, the insights gained from this study will be valuable for clinicians seeking to alleviate depressive symptoms in MDD through neuromodulation techniques such as iTBS.
Trial Details
NCT Number NCT06773949
Lead Sponsor The Royal Ottawa Mental Health Centre
Collaborators: University of Ottawa
Conditions Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov