Status:
UNKNOWN
Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial
Lead Sponsor:
Centre Hospitalier St Anne
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 12 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06085950
Start Date
May 9 2023
End Date
June 12 2024
Last Update
October 17 2023
Active Locations (1)
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1
GHU Sainte-Anne
Paris, France, 75014