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

Launched by CENTRE HOSPITALIER ST ANNE · Oct 10, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option called Transcranial Ultrasonic Stimulation (TUS) for people who have treatment-resistant depression (TRD). This means the study is looking at individuals who have not found relief from their depression despite trying at least two different antidepressant medications. The goal is to refine how TUS is applied and to get an early sense of how well it works for these patients.

To be eligible for the trial, participants need to be between 18 and 75 years old and must have a diagnosis of major depressive disorder, characterized by a severe depressive episode. They should have had stable antidepressant treatment for at least four weeks before joining the study. However, individuals with other psychiatric disorders, neurological issues, or certain medical conditions may not be eligible. Participants will receive TUS treatment and will be monitored to see how they respond. This trial is currently recruiting, and it offers a potential new avenue for those who have struggled to find effective treatment for their depression.

Gender

ALL

Eligibility criteria

• 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