NCT06085950

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
Last Updated

October 17, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 12, 2023

Last Update Submit

October 10, 2023

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

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

    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.

    Pre-treatment and Day 5 from start of intervention

Secondary Outcomes (7)

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

    Day 1 to Day 35 from start of intervention

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

    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

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

    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

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

    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

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

    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

  • +2 more secondary outcomes

Study Arms (1)

Transcranial Ultrasonic Stimulation with Personalized Acoustic Lens

EXPERIMENTAL

Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull

Device: Transcranial Ultrasonic Stimulation prototype

Interventions

Transcranial Ultrasonic Stimulation prototypeDEVICE

Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation

Transcranial Ultrasonic Stimulation with Personalized Acoustic Lens

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Benefiting from a social security scheme
  • Having given their consent to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHU Sainte-Anne

Paris, 75014, France

RECRUITING

Related Publications (1)

  • Attali D, Tiennot T, Manuel TJ, Daniel M, Houdouin A, Annic P, Dizeux A, Haroche A, Dadi G, Henensal A, Moyal M, Le Berre A, Paolillo C, Charron S, Debacker C, Lui M, Lekcir S, Mancusi R, Gallarda T, Sharshar T, Sylla K, Oppenheim C, Cachia A, Tanter M, Aubry JF, Plaze M. Deep transcranial ultrasound stimulation using personalized acoustic metamaterials improves treatment-resistant depression in humans. Brain Stimul. 2025 May-Jun;18(3):1004-1014. doi: 10.1016/j.brs.2025.04.018. Epub 2025 Apr 29.

    PMID: 40311843DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Marion PLAZE

CONTACT

+33 1 45 65 87 20m.plaze@ghu-paris.fr

David ATTALI

CONTACT

d.attali@ghu-paris.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

October 17, 2023

Study Start

May 9, 2023

Primary Completion

May 13, 2024

Study Completion

June 12, 2024

Last Updated

October 17, 2023

Record last verified: 2023-09

Locations

FR(1)