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NCT Number: NCT06085950

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

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHU Sainte-Anne

Paris, 75014, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Ultrasonic Stimulation prototype

Device

Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation

Primary outcomes

  1. Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint

    Time frame: Pre-treatment and Day 5 from start of intervention

    MADRS is a ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.

Secondary outcomes

  1. Incidence of serious adverse reactions according to the Common Terminology Criteria for Adverse Events (CTCAE) scale

    Time frame: Day 1 to Day 35 from start of intervention

    CTCAE are a set of criteria for the standardized classification of adverse effects

  2. Percent change in the Montgomery-Åsberg Depression Scale (MADRS)

    Time frame: Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention

    MADRS is a ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.

  3. Percent change in the Hamilton Rating Scale for Depression (HDRS-17)

    Time frame: Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention

    HDRS-17 is a 17 item questionnaire used to score the severity of depression. Scale range - 0 to 52 with higher score indicative of greater depressive symptomology.

  4. Percent change in the Hamilton Rating Scale for Depression (HDRS-6)

    Time frame: Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention

    HDRS-6 is a 6 item questionnaire used to score the severity of depression. Scale range - 0 to 22 with higher score indicative of greater depressive symptomology.

  5. Percent change in the Inventory of Depressive Symptomatology (IDC-C)

    Time frame: Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention

    IDS-C is a 30 item questionnaire used to score the severity of depression. Scale range - 0 to 90 with higher score indicative of greater depressive symptomology.

  6. Percent change in the Quick Inventory of Depressive Symptomatology (QIDS-SR)

    Time frame: Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention

    QIDS-SR is a 16 item self-administered questionnaire used to score the severity of depression. Scale range - 0 to 27 with higher score indicative of greater depressive symptomology.

  7. Assess the changes in functional connectivity of sgACC after TUS

    Time frame: Pre-treatment and Day 7 from start of intervention

    Comparison of functional connectivity of subgenual cingulate cortex through resting state imaging analysis before / after intervention

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study title

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

Acronym: StimulUS

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 17, 2023
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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