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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06085950
Other study ID # D21-P020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 9, 2023
Est. completion date June 12, 2024

Study information

Verified date September 2023
Source Centre Hospitalier St Anne
Contact Marion PLAZE
Phone +33 1 45 65 87 20
Email m.plaze@ghu-paris.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 12, 2024
Est. primary completion date May 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcranial Ultrasonic Stimulation prototype
Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation

Locations

Country Name City State
France GHU Sainte-Anne Paris

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Incidence of serious adverse reactions according to the Common Terminology Criteria for Adverse Events (CTCAE) scale CTCAE are a set of criteria for the standardized classification of adverse effects Day 1 to Day 35 from start of intervention
Secondary Percent change in the Montgomery-Åsberg Depression Scale (MADRS) 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 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
Secondary Percent change in the Hamilton Rating Scale for Depression (HDRS-17) 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. 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
Secondary Percent change in the Hamilton Rating Scale for Depression (HDRS-6) 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. 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
Secondary Percent change in the Inventory of Depressive Symptomatology (IDC-C) 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. 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
Secondary Percent change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) 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. 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
Secondary Assess the changes in functional connectivity of sgACC after TUS Comparison of functional connectivity of subgenual cingulate cortex through resting state imaging analysis before / after intervention Pre-treatment and Day 7 from start of intervention
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