Clinical trial NCT06085950: Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial
Official title: Transcranial Ultrasonic Stimulation in Treatment-resistant Depression: an Open-label Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment Resistant Depression
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint
timeFrame: Pre-treatment and Day 5 from start of intervention
Secondary outcomes:
measure: Incidence of serious adverse reactions according to the Common Terminology Criteria for Adverse Events (CTCAE) scale
timeFrame: Day 1 to Day 35 from start of intervention
measure: Percent change in the Montgomery-Åsberg Depression Scale (MADRS)
timeFrame: 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
measure: Percent change in the Hamilton Rating Scale for Depression (HDRS-17)
timeFrame: 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
measure: Percent change in the Hamilton Rating Scale for Depression (HDRS-6)
timeFrame: 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
measure: Percent change in the Inventory of Depressive Symptomatology (IDC-C)
timeFrame: 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
measure: Percent change in the Quick Inventory of Depressive Symptomatology (QIDS-SR)
timeFrame: 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
measure: Assess the changes in functional connectivity of sgACC after TUS
timeFrame: Pre-treatment and Day 7 from start of intervention
Other outcomes:
Locations:
city: Paris
country: France
facility: GHU Sainte-Anne
Study officials:
References: