Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382389
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-19
Brief Title:
Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders a Randomized Controlled Trial-
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTO-EHPAD
Brief Summary:
Depression in neurocognitive disorders Alzheimers disease and related disoders is a highly prevalent condition especially in nursing homes While it is associated with significant distress the current conventional antidepressants have shown only modest efficacy and exposed to potentially severe side effects
Recent evidence suggests that nitrous oxide N2O in its most commonly used packaging of EMONO Equimolar Mixture of Oxygen and Nitrous Oxide has rapid antidepressant properties and a good safety profile However no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes
The principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks with a dosage escalation procedure
Recent evidence suggests that nitrous oxide N2O in its most commonly used packaging of EMONO Equimolar Mixture of Oxygen and Nitrous Oxide has rapid antidepressant properties and a good safety profile However no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes
The principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks with a dosage escalation procedure
Detailed Description:
Participants will be exposed to 3 sessions of EMONO or Medical Air with intervals of 1 week between sessions a first session of 20 minutes a second of 40 minutes one week later and a final session of 60 minutes one week later Efficacy will be assessed 1 week after each session and 4 weeks after the last session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504691-18-00 | CTIS | None | None |