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NCT03421574
Trial of MR-guided Focused Ultrasound for Treatment of Refractory Major Depression
NA trial testing MR-guided Focused Ultrasound in Major Depressive Disorder in 18 participants. Completed in 28 July 2021.
28 July 2021
Quick facts
| Lead sponsor | Sunnybrook Health Sciences Centre |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 19 January 2018 |
| Primary completion | 28 July 2021 |
| Estimated completion | 28 July 2021 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- MR-guided Focused Ultrasound
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
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):
-
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03421574
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03421574 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sunnybrook Health Sciences Centre
- Last refreshed: 5 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03421574.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing