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Sound waves to the brain: a new hope for Treatment-Resistant depression?

NCT ID NCT06085950

Symptom relief Sponsor: Centre Hospitalier St Anne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study explores whether low-intensity ultrasound waves aimed at specific brain areas can ease symptoms in people with treatment-resistant depression. Thirty-two adults aged 18 to 75 who have not responded to at least two antidepressant treatments will receive personalized ultrasound stimulation. Researchers will measure changes in depression severity using a standard scale and monitor for any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcranial ultrasonic stimulation prototype
What this could lead to
If effective, this could offer a non-invasive, drug-free option for people with depression that hasn't responded to standard treatments.
What could go wrong
This is a small, early pilot study without a placebo group, so results may not prove effectiveness. The approach is experimental and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Treatment-resistant depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GHU Sainte-Anne

    RECRUITING

    Paris, 75014, France

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