Trials / Not Yet Recruiting
Not Yet RecruitingNCT06382389
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-
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- Sponsor
- University Hospital, Tours · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EMONO | Exposure of Emono via facial mask |
| DRUG | Medical air | exposure to Medical Air |
Timeline
- Start date
- 2024-06-01
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2024-04-24
- Last updated
- 2024-04-24
Source: ClinicalTrials.gov record NCT06382389. Inclusion in this directory is not an endorsement.