Recruiting
Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial
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.
ClinicalTrials.gov IDNCT06085950
PhaseNA
Enrollment32
SponsorCentre Hospitalier St Anne
Age18 Years
SexALL
Conditions studied
Treatment Resistant Depression
About this study
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.
Interventions
- Device: Transcranial Ultrasonic Stimulation prototype — Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation
Primary outcomes
- Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint (Pre-treatment and Day 5 from start of intervention)
Eligibility information
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
Study locations
- GHU Sainte-Anne, Paris, 75014 France
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.