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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 60 and over living in nursing home
- •Diagnosis of major neurocognitive disorder according to DSM-V for at least 6 month
- •MMSE <= 20/30
- •NPI depression >= 4/12
- •Patient, family and legal representive consent where applicable Person affiliated to a social security schem
排除标准
- •NPI agitation > 6/12
- •Unstable somatic pathology (in particular unstable neurological or cardiological pathologies at risk of interfering with the diffusion of MEOPA) and any unexplained recent neurological abnormality.
- •Contraindications to the use of MEOPA
- •Patients who have already been treated with MEOPA in the 6 months prior to inclusion, for example for painful treatment
- •Sub-physiological plasma vitamin B12 or B9 concentration (below the lower limit of the laboratory value).
- •A person participating in a clinical drug study or in a period of exclusion from any clinical study due to previous participation
- •Personne participant à une étude clinique médicamenteuse ou en période d'exclusion de toute étude clinique du fait d'une précédente participation
研究组 & 干预措施
EMONO
Equimolar Mixture of Oxygen and Nitrous Oxide (50%O2 / 50%N2O) Active drug: Nitrous Oxide
干预措施: EMONO (Drug)
medical air
Comparator : medical Air (78% N2 / 22% O2)
干预措施: Medical air (Drug)
结局指标
主要结局
Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline).
时间窗: baseline, week 4
The CORNELL is a validated scale specifically designed for depression in major neurocognitive disorders
次要结局
- CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8(baseline, weeks 1, 2, 3, 4 and 8)
- CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8(baseline, weeks 1, 2, 3, 4 and 8)
- The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8(baseline, weeks 1, 2, 3, 4 and 8)
- Collection of adverse events at all study visits(baseline, weeks 1, 2, 3, 4 and 8)