Treatment Resistant Depression
Conditions
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.
Interventions
DEVICETranscranial Ultrasonic Stimulation prototype
Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation
Sponsors
Centre Hospitalier St Anne
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | CTCAE are a set of criteria for the standardized classification of adverse effects |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Assess the changes in functional connectivity of sgACC after TUS | 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 |
Countries
France
Contacts
CONTACTMarion PLAZE
CONTACTDavid ATTALI
Outcome results
None listed