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Nitrous Oxide in Resistant Depression in Elderly Subjects: A Randomized, Double-blind, Comparator Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517549-15-00
Acronym
PROTO-BRAIN
Enrollment
60
Registered
2024-11-12
Start date
2021-11-16
Completion date
2024-12-19
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistant Depression in the Elderly Subject

Brief summary

MADRS Depression Severity Scale collected collected at baseline, 2 hours, 24 hours, Week 1 and Week 2 in MEOPA vs comparator group

Detailed description

Brain Pulsatility Indices as measured by IPT Ultrasound Imaging, Brain volume and white matter lesion indices measured by MRI, indicators of brain atrophy and lesion load; Brain perfusion indices measured by MRI-ASL; Pulsatilité́ and Brain Connectivity indices as measured by MRI in BOLD signal, A series of scales complementary to the MADRS for the evolution of depressive symptoms (Hamilton 17-items, CGI - Clinical Global Impression, QIDS-SR - Quick Inventory of Depressive Symptomatology Self Report), A series of scales for the evaluation of possible adverse effects (SSI - Scale for Suicidal Ideation, YMRS - Young Mania Rating Scale, CADSS - Clinician Administered Dissociative States Scale, BPRS - Brief Psychiatric Rating Scale)

Interventions

Sponsors

Centre Hospitalier Regional Universitaire De Tours
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
MADRS Depression Severity Scale collected collected at baseline, 2 hours, 24 hours, Week 1 and Week 2 in MEOPA vs comparator group

Secondary

MeasureTime frame
Brain Pulsatility Indices as measured by IPT Ultrasound Imaging, Brain volume and white matter lesion indices measured by MRI, indicators of brain atrophy and lesion load; Brain perfusion indices measured by MRI-ASL; Pulsatilité́ and Brain Connectivity indices as measured by MRI in BOLD signal, A series of scales complementary to the MADRS for the evolution of depressive symptoms (Hamilton 17-items, CGI - Clinical Global Impression, QIDS-SR - Quick Inventory of Depressive Symptomatology Self Report), A series of scales for the evaluation of possible adverse effects (SSI - Scale for Suicidal Ideation, YMRS - Young Mania Rating Scale, CADSS - Clinician Administered Dissociative States Scale, BPRS - Brief Psychiatric Rating Scale)

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026