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NCT03421574

Trial of MR-guided Focused Ultrasound for Treatment of Refractory Major Depression

Completed NA Last updated 5 December 2023
What this trial tests

NA trial testing MR-guided Focused Ultrasound in Major Depressive Disorder in 18 participants. Completed in 28 July 2021.

Timeline
19 January 2018
Primary endpoint
28 July 2021
28 July 2021

Quick facts

Lead sponsorSunnybrook Health Sciences Centre
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment18
Start date19 January 2018
Primary completion28 July 2021
Estimated completion28 July 2021
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Sunnybrook Health Sciences Centre — full company profile →

Who can join

Adults 20 to 80, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with treatment-refractory Major Depression. This study is designed as a prospective, single arm, nonrandomized study. Assessments will be made before and after MRgFUS for adverse events related to treatment, for clinical symptom relief, and quality of life (QoL). The target in the brain chosen for ablation will be the anterior limb of the internal capsule (i.e 'capsulotomy').

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Magnetic Resonance-Guided Focused Ultrasound : Current Status and Future Perspectives in Thermal Ablation and Blood-Brain Barrier Opening.
    Lee EJ, Fomenko A, Lozano AM. · · 2019 · cited 45× · PMID 30630292 · DOI 10.3340/jkns.2018.0180
  2. Magnetic Resonance-Guided Focused Ultrasound in Neurosurgery: Taking Lessons from the Past to Inform the Future.
    Jung NY, Chang JW. · · 2018 · cited 24× · PMID 30369860 · DOI 10.3346/jkms.2018.33.e279
  3. Examining cognitive change in magnetic resonance-guided focused ultrasound capsulotomy for psychiatric illness.
    Davidson B, Hamani C, Meng Y, Baskaran A, et al · · 2020 · cited 18× · PMID 33177508 · DOI 10.1038/s41398-020-01072-1
  4. Targeted manipulation of pain neural networks: The potential of focused ultrasound for treatment of chronic pain.
    Todd N, McDannold N, Borsook D. · · 2020 · cited 13× · PMID 32534900 · DOI 10.1016/j.neubiorev.2020.06.007
  5. Commonly used outcome measures in neurosurgical trials for major depressive disorder might not capture clinically meaningful treatment effects.
    Rabin JS, Nyman AJ, Davidson B, Zakzanis KK, et al · · 2022 · cited 4× · PMID 35078915 · DOI 10.1136/jnnp-2021-327688
  6. Ultrasound Applications in the Treatment of Major Depressive Disorder: A Systematic Review of Techniques and Therapeutic Potentials in Clinical Trials and Animal Model Studies.
    Tan G, Chen H, Leuthardt EC. · · 2026 · cited 1× · PMID 41105071 · DOI 10.1016/j.neurom.2025.08.001

Verify or expand the search:

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

Other Sunnybrook Health Sciences Centre trials

Trials by the same sponsor.

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Data sources for this page

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