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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCentre Hospitalier St Anne

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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, …)

Trial design

Treatments tested in this trial

  • Transcranial Ultrasonic Stimulation prototype

Treatment groups

32 Participants
are divided into 4 treatment groups

Sponsors and collaborators