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Biomarker-guided rTMS for Treatment Resistant Depression

Study acronym: BioTMS
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Apr 2026 to Apr 2027
    • Study completion date: Aug 2026 to Aug 2027
    • Site contacts updated at 1 of 2 sites
    v13
  2. Re-verified, no change to tracked fieldsv12
  3. Start date: Sep 1, 2021 to Sep 17, 2021v11
  4. Study sites: 1 to 2
    • Eligibility criteria revised
    • Collaborators: 1 to 2
    v10
  5. 2 versions Re-verified since Mar 24, 2022, no change to tracked fieldsv8-v9
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Not Yet Recruiting to Recruitingv7 Show 6 more changesShow less
    • Enrollment target: 464 to 348
    • Start date changed from estimate of Aug 1, 2021 to Sep 1, 2021
    • Eligibility criteria expanded, about 291 words
    • Secondary endpoints: 3 to 2
    • Study description expanded, about 66 words
    • Site details revised
  2. Primary completion date: Feb 2025 to Apr 2026
    • Start date: Mar 1, 2021 to Aug 1, 2021
    • Study sites: 2 to 1
    • Study completion date: Feb 2025 to Aug 2026
    v6
  3. Start date: Sep 1, 2020 to Mar 1, 2021v5
  4. Primary and study completion dates: May 2024 to Feb 2025v4 Show 4 more changesShow less
    • Start date: May 1, 2020 to Sep 1, 2020
    • Secondary endpoints: 2 to 3
    • Site contacts updated at 1 of 2 sites
    • Collaborators: 2 to 1
  5. Start date: Dec 2, 2019 to May 1, 2020v3
  6. Start date: Sep 3, 2019 to Dec 2, 2019
    • Primary and study completion dates: Feb 2024 to May 2024
    • Site contacts updated at 1 of 2 sites
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 treatment for depression. The investigators are continuing to learn how to optimize outcomes from rTMS treatment. The purpose of this research project is to use brain network connectivity patterns as measured by resting state functional magnetic resonance imaging (fMRI) to confirm a way to optimize the use of rTMS to treat depression. In addition, the study aims to gain a better understanding of how rTMS influences brain networks.
Trial Details
NCT Number NCT04041479
Lead Sponsor Weill Medical College of Cornell University
Collaborators: National Institute of Mental Health (NIMH), Stanford University
Conditions
(from sponsor)		 Treatment Resistant Depression, Major Depressive Disorder
Related terms Depressive Disorder, Treatment-Resistant, Major Depressive Disorder
Enrollment 348 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov