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

ConditionTreatment Resistant Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCentre Hospitalier St Anne

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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, …)

Trial design

Design model

Sequential

Treatments tested in this trial

  • Transcranial Ultrasonic Stimulation prototype

    Device

    Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: TUS - 5 min sessions, 5% duty cycle, 5 sessions/day (n=5)Experimental treatment 1 intervention
Group B: TUS - 40 min sessions, 5% duty cycle, 2 sessions/day (n=7)Experimental treatment 1 intervention
Group C: TUS - 40 min sessions, 1% duty cycle, increased acoustic power, 2 sessions/day (n=10)Experimental treatment 1 intervention
Group D: TUS - 40 min sessions, 5% duty cycle, increased acoustic power, 2 sessions/day (n=10)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
Pre-treatment and Day 5 from start of intervention

Secondary outcomes

1

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

Time frame
Day 1 to Day 35 from start of intervention
2

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.

Time frame
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
3

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.

Time frame
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
4

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.

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier St Anne

Lead sponsor

Source ClinicalTrials.gov
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