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

Phase 1

• Conditions: Resistant Depression in the Elderly Subject; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-004984-31-FR
• Lead Sponsor: CHRU TOURS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-15
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified