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

Centre Hospitalier St Anne1 site in 1 country10 target enrollmentMay 9, 2023

ConditionsTreatment Resistant Depression

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Treatment Resistant Depression
Sponsor: Centre Hospitalier St Anne
Enrollment: 10
Locations: 1
Primary Endpoint: Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 9, 2023

End Date

June 12, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier St Anne

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

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)
Assess the changes in functional connectivity of sgACC after TUS(Pre-treatment and Day 7 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)
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 Quick Inventory of Depressive Symptomatology (QIDS-SR)(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)