Home Diseases and Conditions Depression

Depression

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites. There are also clinical trials that may be of interest to patients.

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with depression. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue. 

How it Works
Where the beams converge, focused ultrasound produces thermal ablation, meaning that the targeted tissue is heated and destroyed where the beams converge. Additional research is using neuromodulation, where lower intensity focused ultrasound is used to alter the activity of targets to improve depression.

Advantages
Current treatments for depression include medications, electroconvulsive therapy, surgery (radiofrequency or laser ablation, deep brain stimulation), or stereotactic radiosurgery (gamma knife, linear accelerator), all of which have limitations and side effects.

Focused ultrasound has the potential to provide an alternative to invasive surgery or radiosurgery via precise thermal ablation, or to augment drug therapy.

Focused ultrasound is noninvasive – no incisions, holes in the skull, electrodes in the brain – and therefore has reduced risk for infection and blood clots. It also enables precise targeting and minimizes damage to non-targeted, healthy brain. Focused ultrasound can also be a complement to drug therapy, enabling enhanced delivery of therapies into the brain via temporary opening of the blood-brain barrier.

Clinical Trials

A clinical trial in Utah is using low intensity focused ultrasound to treat patients with depression. 

A clinical trial in South Carolina is using low intensity focused ultrasound to treat patients with treatment resistant depression.  

A clinical trial in Ontario, Canada is using the next generation dome helmet to treat patients with treatment resistant depression.   

A clinical trial in France is using low intensity focused ultrasound to treat patients with treatment resistant depression.  

A clinical trial in Rhode Island is using neuromodulation to the amygdala to treat depression.

A clinical trial in Los Angeles is treating depression. This trial is recruiting patients by invitation.

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/

See here for a list of treatment sites
See here for a list of clinical trials sites
See here for a list of laboratory research sites

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement

Focused ultrasound is only approved by for the treatment of depression in Korea. Outside of the South Korean National Health Insurance System, we are not aware of this treatment reimbursed by any other medical insurance providers.

Additional Resources

National Institute of Mental Health
One Mind
Depression and Bipolar Support Alliance

Notable Papers

Mirjalili M, Blumberger DM, Brunoni AR, Mulsant BH, Rajji TK. Neuromodulation and cognition in late-life depression. Neuropsychopharmacology. 2026 Jan 17. doi: 10.1038/s41386-026-02323-3. PMID: 41545465 

Arulpragasam AR, Philip NS. Quiet waves, deep impact: acoustic modeling of low-intensity focused ultrasound. Neuropsychopharmacology. 2026 Jan;51(1):351-353. doi: 10.1038/s41386-025-02191-3. PMID: 40764758 

Wang F, Ye K, Paerhati H, Suo J, Shen Z, Zhang J, Li D, Zhan S, Lai Y, Sun B. Imaging characteristics correlated with outcomes of cranial MRgFUS – a systematic review. Neuroimage. 2025 Nov 7;323:121571. doi: 10.1016/j.neuroimage.2025.121571. PMID: 41207452 

Luo Y, Luo K, Zhang X, Feng X, Lei L, Cheng S, Meng F, Xu X, Chen M, Ao L. Low-intensity focused ultrasound stimulation on the hippocampus improved CSDS-induced neuroinflammation through the Notch1 signaling pathway. J Affect Disord. 2025 Dec 1;390:119793. doi: 10.1016/j.jad.2025.119793. Epub 2025 Jun 30. PMID: 40602537 

Ahmadnia H, Abdollahzadeh R, Hatami H, Masoumi S, Moezzi SMI, Shahsavari K, Khanavi M, Yazarlu O, Tohidy Majd M, Hasanpour M. Neurobiological mechanisms and recent advances in drug-based therapeutics in depression. Neuroscience. 2025 Nov 6;590:120-142. doi: 10.1016/j.neuroscience.2025.11.002. PMID: 41205901 

Wang P, Gao Y, Li H, Tian J, Chai S, Zhou Z, Huang X, Bao W, Hu X, Zhang L, Xing H, Li B, Gong Q, Huang X. Comparison of multiple non-invasive neuromodulation strategies for depressive episodes in major depressive disorder and bipolar disorder: A systematic review and network meta-analysis of randomized controlled trials. Psychiatry Clin Neurosci. 2025 Nov 11. doi: 10.1111/pcn.13918. PMID: 41217021 

Polte S, Klingmann L, Seßmann A, Schwichtenberg S, Herrmann CS, Witt K, Roheger M. Neuromodulatory Effects of Transcranial Pulse Stimulation (TPS) in Neurological and Psychiatric Disorders-A Systematic Review and Meta-Analysis. Neurol Int. 2025 Nov 18;17(11):188. doi: 10.3390/neurolint17110188. PMID: 41295447 

De Schlichting E, Huang Y, Jones RM, Meng Y, Cao X, Baskaran A, Hynynen K, Hamani C, Lipsman N, Goubran M, Davidson B. Focused ultrasound capsulotomy: predicting the probability of successful lesioning based on skull morphology. J Neurosurg. 2025 Oct 10:1-10. doi: 10.3171/2025.6.JNS2588. PMID: 41072044 

Du A, Huang M, Wang Z, Zhou H, Duan H, Hu S, Zheng Y. Using Low-Intensity Focused Ultrasound to Treat Depression and Anxiety Disorders: A Review of Current Evidence. Brain Sci. 2025 Oct 21;15(10):1129. doi: 10.3390/brainsci15101129. PMID: 41154223

Tan G, Chen H, Leuthardt EC. Ultrasound Applications in the Treatment of Major Depressive Disorder: A Systematic Review of Techniques and Therapeutic Potentials in Clinical Trials and Animal Model Studies. Neuromodulation. 2025 Oct 16:S1094-7159(25)00275-2. doi: 10.1016/j.neurom.2025.08.001. PMID: 41105071 

Tsuchiyagaito A, Kuplicki R, Misaki M, Edwards L, Camprodon JA, Fitzgerald K, Khalsa SS, Philip NS, Paulus MP, Guinjoan SM. Reversible modulation of a deep white matter surgical target for depression with low-intensity focused ultrasound. Neuropsychopharmacology. 2025 Sep 25. doi: 10.1038/s41386-025-02252-7. PMID: 40999237 

Michalopoulou PG, Meshreky KM, Hommerich Z, Shergill SS. Neuromodulation and neural networks in psychiatric disorders: current status and emerging prospects. Psychol Med. 2025 Sep 26;55:e281. doi: 10.1017/S003329172510158X. PMID: 40999798 

Martin E, Roberts M, Grigoras IF, Wright O, Nandi T, Rieger SW, Campbell J, den Boer T, Cox BT, Stagg CJ, Treeby BE. Ultrasound system for precise neuromodulation of human deep brain circuits. Nat Commun. 2025 Sep 5;16(1):8024. doi: 10.1038/s41467-025-63020-1. PMID: 40913042  

Li W, Feng Y, Xu Z, Xu X, Yang K, Yao X, Pan JJ, Cui H, Hu J, Cheng B. Precise antibody delivery to the brain via nanobubble-actuated focused ultrasound alleviates depression. Proc Natl Acad Sci U S A. 2025 Sep 2;122(35):e2421800122. doi: 10.1073/pnas.2421800122. Epub 2025 Aug 27. PMID: 40864654 

Tsai CC, Fan CH, Lin CW, Bouakaz A, Yeh CK. Focused ultrasound-triggered escitalopram delivery using microbubble-liposome complexes for rapid and sustained serotonin regulation in depression therapy. Biomed Pharmacother. 2025 Jul 17;190:118373. doi: 10.1016/j.biopha.2025.118373. PMID: 40680671 

Davidson B, Xhima K, Cosgrove R, Hamani C, Eitan R, Rezai A, LeBlang S, Philip NS, Lipsman N. A roadmap for focused ultrasound applications in psychiatry: Proceedings of the 2024 Symposium on Focused Ultrasound in Psychiatry (FUS-PULSE). Brain Stimul. 2025 Aug 23:S1935-861X(25)00305-5. doi: 10.1016/j.brs.2025.08.012. PMID: 40846278 

Rotstein NM, Cohen ZD, Welborn A, Zbozinek TD, Akre S, Jones KG, Null KE, Pontanares J, Sanchez KL, Flanagan DC, Halavi SE, Kittle E, McClay MG, Bui AAT, Narr KL, Welsh RC, Craske MG, Kuhn TP. Investigating low intensity focused ultrasound pulsation in anhedonic depression-A randomized controlled trial. Front Hum Neurosci. 2025 Mar 24;19:1478534. doi: 10.3389/fnhum.2025.1478534. eCollection 2025. PMID: 40196448  

Darmani G, Ramezanpour H, Sarica C, Annirood R, Grippe T, Nankoo JF, Fomenko A, Santyr B, Zeng K, Vetkas A, Samuel N, Davidson B, Fasano A, Lankarany M, Kalia SK, Pichardo S, Lozano AM, Chen R. Individualized non-invasive deep brain stimulation of the basal ganglia using transcranial ultrasound stimulation. Nat Commun. 2025 Mar 19;16(1):2693. doi: 10.1038/s41467-025-57883-7.PMID: 40108143  

Riva-Posse P, Figee M. A Safe Step in the Right Direction: Focused Ultrasound in Obsessive-Compulsive Disorder and Depression. Biol Psychiatry. 2025 Apr 1;97(7):664-665. doi: 10.1016/j.biopsych.2025.01.024. PMID: 40086896 

de Souza DN, Seas A, Blethen K, Feigal J, Shah BR, Grant GA, Harward SC. Focused ultrasound as an emerging therapy for neuropsychiatric disease: Historical perspectives and a review of current clinical data. Psychiatry Clin Neurosci. 2025 Feb 12. doi: 10.1111/pcn.13799. PMID: 39936841 

Shi Y, Wu W. Advances in transcranial focused ultrasound neuromodulation for mental disorders. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Jan 10;136:111244. doi: 10.1016/j.pnpbp.2024.111244. Epub 2025 Jan 3. PMID: 39756638 

Hamani C, Davidson B, Rabin JS, Goubran M, Boone L, Hynynen K, De Schlichting E, Meng Y, Huang Y, Jones RM, Baskaran A, Marawi T, Richter MA, Levitt A, Nestor SM, Giacobbe P, Lipsman N. Long-term safety and efficacy of focused ultrasound capsulotomy for obsessive-compulsive disorder and major depressive disorder. Biol Psychiatry. 2024 Aug 24:S0006-3223(24)01548-8. doi: 10.1016/j.biopsych.2024.08.015. PMID: 39187171 

Henn MC, Smith HD, Lopez Ramos CG, Shafie B, Abaricia J, Stevens I, Rockhill AP, Cleary DR, Raslan AM. A systematic review of focused ultrasound for psychiatric disorders: current applications, opportunities, and challenges. Neurosurg Focus. 2024 Sep 1;57(3):E8. doi: 10.3171/2024.6.FOCUS24278. PMID: 39217636 

Oh J, Ryu JS, Kim J, Kim S, Jeong HS, Kim KR, Kim HC, Yoo SS, Seok JH. Effect of Low-Intensity Transcranial Focused Ultrasound Stimulation in Patients With Major Depressive Disorder: A Randomized, Double-Blind, Sham-Controlled Clinical Trial. Psychiatry Investig. 2024 Aug;21(8):885-896. doi: 10.30773/pi.2024.0016. Epub 2024 Aug 8. PMID: 39111747 

Fan JM, Woodworth K, Murphy KR, Hinkley L, Cohen JL, Yoshimura J, Choi I, Tremblay-McGaw AG, Mergenthaler J, Good CH, Pellionisz PA, Lee AM, Di Ianni T, Sugrue LP, Krystal AD. Thalamic transcranial ultrasound stimulation in treatment resistant depression. Brain Stimul. 2024 Aug 22;17(5):1001-1004. doi: 10.1016/j.brs.2024.08.006. PMID: 39173737 

Dos Santos Alves Maria G, Dias NS, Nicolato R, de Paula JJ, Bicalho MAC, Cunha RS, Silva LC, de Miranda DM, de Mattos Viana B, Romano-Silva MA. Safety and efficacy of repetitive stimulation of the left dorsolateral prefrontal cortex using transcranial focused ultrasound in treatment-resistant depressed patients: A non-inferiority randomized controlled trial protocol. Asian J Psychiatr. 2024 May;95:103994. doi: 10.1016/j.ajp.2024.103994. Epub 2024 Mar 16. PMID: 38547573 

Hurwitz TA, Avecillas-Chasin JM, Bogod NM, Honey CR. Ventral targeted anterior capsulotomy for treatment-resistant depression and obsessive-compulsive disorder: A treatment method with cases. J Affect Disord. 2024 Jan 23;350:887-894. doi: 10.1016/j.jad.2024.01.176. PMID: 38272366 

Click here for additional references from PubMed.