Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial
Recruiting · NCT06085950 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier St Anne
View the official record on ClinicalTrials.gov →Interventions studied
Transcranial Ultrasonic Stimulation prototype
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- GHU Sainte-Anne - Paris, France