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Clinical Trials in France / NCT06085950
Recruiting Not applicable

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

NCT06085950 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier St Anne
Phase
Not applicable
Started
2023-05-09
Last updated
2026-06-22

Condition(s) studied

Treatment Resistant Depression

Investigational drug(s) / intervention(s)

Transcranial Ultrasonic Stimulation prototype

Transcranial Ultrasonic Stimulation prototype: Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint — Pre-treatment and Day 5 from start of intervention
    MADRS is a ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.

Trial sites (1)

FacilityCityRegionStatus
GHU Sainte-Anne Paris France Recruiting

More Centre Hospitalier St Anne trials in France

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Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ) Recruiting
Implications of Myelin in Executive Control in Adolescence and Early Adulthood Recruiting
Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT Recruiting

Other trials for the same condition

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD Active, not recruiting
Belief Updating in Treatment Resistant Depression Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06085950 on ClinicalTrials.gov ↗ ← All trials in France