Nitrous Oxide for Late-Life Depression - PROTO-BRAIN

Launched by UNIVERSITY HOSPITAL, TOURS · Aug 13, 2021

Keywords

ClinConnect Summary

The PROTO-BRAIN clinical trial is exploring the use of nitrous oxide (commonly known as laughing gas) as a potential treatment for late-life depression, especially in older adults who have not found relief with traditional antidepressants. Researchers want to see if breathing in a mixture of nitrous oxide and oxygen can improve mood and reduce symptoms of depression in people aged 60 to 90 who have been diagnosed with major depression and have not responded to previous treatments.

To participate in this study, individuals must be between 60 and 90 years old, have a significant level of depression, and have tried at least one antidepressant without success. Participants will receive either the nitrous oxide mixture or medical air for one hour, and their mood will be assessed at various times afterwards, including after 2 hours, 24 hours, one week, and two weeks. The study is currently recruiting participants, and those who are eligible will be thoroughly informed about what to expect and will need to provide consent to take part. This trial aims to find a new approach to help older adults struggling with depression, which is a pressing need in mental health care.

Gender

ALL

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