Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
NCT ID:
NCT05007028
Eligibility Criteria:
Inclusion Criteria:
* Aged 60-90 years-old
* Major Depressive Episode according to DSM-5 criteria, confirmed by the MINI - Mini International Neuropsychiatric Interview
* MADRS score greater than 20 (Montgomery Asberg Depression Rating Scale)
* Patient resistant to at least one well-conducted antidepressant treatment, as documented by the MGH-ATRQ scale
* Patient who can undergo N2O diffusion via a facial mask
* Patient who has signed an informed consent
* Person affiliated with a social security scheme
Exclusion Criteria:
* Bipolar disorder, schizophrenic disorder, neurodegenerative disease, documented by the MINI and the MMSE (non-inclusion if MMSE \< 24/30), addictive disorder
* Unstable somatic pathology (including unstable neurological or cardiological diseases at risk of interfering with N2O diffusion)
* Presence of active and significant psychotic symptoms, at investigator's discretion
* Contraindications to EMONO (50%N2O/ 50%O2) : pneumothorax, emphysema, bowel obstruction, intracranial hypertension, chronic deficiency in vitamin B12 or B9
* Contraindications to MRI, including claustrophobia
* Legal incapacity and/or other circumstances unabling the patient to understand the nature, purpose or consequences of the study
* A person participating in a drug clinical trial or during a period of exclusion from any clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
90 Years
Study:
NCT05007028
Study Brief:
Protocol Section:
NCT05007028