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

RECRUITINGN/ASponsored by Centre Hospitalier St Anne
Actively Recruiting
PhaseN/A
SponsorCentre Hospitalier St Anne
Started2023-05-09
Est. completion2028-05
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06085950

Summary

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.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Conditions2

DepressionTreatment-resistant Depression

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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