Using Transcranial Ultrasonic Stimulation for Treatment-Resistant Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to optimize the protocol for administering Transcranial Ultrasonic Stimulation (TUS) in patients suffering from treatment-resistant depression (TRD). It will evaluate the initial efficacy of TUS in individuals who have not responded to at least two antidepressant treatments. Participants will be aged between 18 and 75 years and must have a severe major depressive episode as defined by established criteria. The study will be conducted in an open-label format at the GHU Sainte-Anne in Paris.

Why it matters

Who can join: the full rules

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's running

• GHU Sainte-Anne
  Paris, France Recruiting

Study contacts

• Study coordinator: Marion PLAZE
• Email: m.plaze@ghu-paris.fr
• Phone: +33 1 45 65 87 20

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Rapid, robot-guided TMS with NRX-101 for treatment-resistant depression

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.