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Comparing Uni- and Bi-lateral TBS in Major Depression

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 4, 2023 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Nov 2023); last known: Recruiting
  2. Primary and study completion dates: Sep 2023 to Sep 2026 Eligibility criteria expanded, about 57 words · Study description shortened, about 5 wordsv4 Show 2 more changesShow less
    • Eligibility criteria expanded, about 57 words
    • Study description shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study description shortened, about 99 words Study arms: 4 to 3 · Eligibility criteria expanded, about 2 wordsv3 Show 2 more changesShow less
    • Study arms: 4 to 3
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date changed from estimate of Oct 2019 to Dec 12, 2019v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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) is a very promising new treatment for major depression that allows a 15-fold reduction in duration of daily sessions. However, no large scale naturalistic study has assessed the superiority of bilateral TBS in comparison with unilateral left TBS. In fact, no TBS study thus far has included both unipolar and bipolar depression, or other psychiatric comorbidities such as anxiety. Maintenance has yet to be studied with TBS, along with an effective maintenance protocol to prevent relapse. Our study aims to explore and address these gaps.
Trial Details
NCT Number NCT04142996
Lead Sponsor The Royal Ottawa Mental Health Centre
Conditions Major Depressive Episode
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov