itrous Oxide in Resistant Depression in Elderly Subjects: A Randomized, Double-blind, Comparator Trial - PROTO-BRAI

CHRU TOURS0 个研究点目标入组 60 人开始时间: 2021年2月15日最近更新: 2021年5月3日

适应症

试验速览

暂无简介。

•- Between 60 and 90 years old.
•- Diagnosis of depressive episode characterized according to DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI).
•- Depression score on the MADRS scale greater than 20 (Montgomery Asberg Depression Rating Scale).
•- Patients resistant to at least one well-conducted antidepressant for the current depressive episode as assessed by the MGH-ATRQ scale.
•- Patients who can be subjected to the delivery of MOEPA via a facial mask.
•- A person who has signed an informed consent form.
•- Person affiliated with a social security or other regime
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•- Bipolar disorder, schizophrenic, neurodegenerative disease documented by MINI and MMSE (non-inclusion if MMSE< 24/30), addiction to one or more toxic substances.
•- Unstable somatic pathology (particularly unstable neurological or cardiological pathologies at risk of interfering with the diffusion of MEOPA)
•- Presence of active and significant psychotic symptoms, at the discretion of the investigator
•- Contraindications to the use of MEOPA: pneumothorax, emphysema, intestinal occlusion, intracranial hypertension, known and unsubstituted vitamin B12 or B9 deficiency.
•- MRI contraindications, especially claustrophobia.
•- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, purpose or consequences of the study.
•- A person participating in a clinical drug study or in a period of exclusion from any clinical study due to previous participation.

发起方

CHRU TOURS