Using Transcranial Ultrasonic Stimulation for Treatment-Resistant Depression
Transcranial Ultrasonic Stimulation in Treatment-resistant Depression: an Open-label Pilot Trial
NA · Centre Hospitalier St Anne · NCT06085950
This study is testing a new treatment called Transcranial Ultrasonic Stimulation to see if it can help adults with severe depression who haven't found relief from other medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06085950 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with severe treatment-resistant depression who have not benefited from multiple antidepressant therapies.
Not a fit: Patients with psychiatric disorders other than mood disorders or those with neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with treatment-resistant depression.
How similar studies have performed: While the use of ultrasonic stimulation in depression treatment is a novel approach, similar studies have shown promise in other neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Treatment Resistant Depression