Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial

Recruiting now · Not applicable

Conditions studied: Treatment Resistant Depression

In brief

The primary objective of this study is to optimize the protocol for the TUS administration in patients with TRD while gaining an initial impression of treatment efficacy.

Key facts

Study ID

NCT06085950

Run by

Centre Hospitalier St Anne

People needed

32

Starts

2023-05-09

Expected to finish

2028-06-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 75 years,
• Diagnosis of major depressive episode (MDE) as part of major depressive disorder as defined by DSM-5 criteria
• Severe MDE (HDRS-17> 20)
• Drug resistance to at least two well-conducted antidepressant treatment lines
• With stable antidepressant treatment for at least 4 weeks before inclusion
• Benefiting from a social security scheme
• Having given their consent to participate

You may not qualify if…

• Psychiatric history other than a mood disorder
• Neurological history, including epilepsy and intracerebral calcifications
• History of substance use disorder other than tobacco
• Contraindication to brain MRI (pacemaker, neurostimulator, injury from metallic shine, …)
• Compulsory psychiatric care
• Protected adults, people under legal safeguard
• Pregnant or breastfeeding woman
• Women of childbearing age who do not have a negative pregnancy test and are not using contraception

Where it is running

• GHU Sainte-Anne — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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