Using Nitrous Oxide to Treat Late-Life Depression
Nitrous Oxide for Late-Life Depression : a Randomized Controlled Trial With Comparator - PROTO-BRAIN
This study is testing if nitrous oxide can help older adults with late-life depression who haven't found relief from regular antidepressants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 1 site (Tours) |
| Trial ID | NCT05007028 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of Nitrous Oxide (N2O) as a treatment for Late-Life Depression (LLD) in older adults who have not responded to traditional antidepressants. Participants aged 60-90 will receive either an equimolar mixture of oxygen and nitrous oxide (EMONO) or medical air, with their depressive symptoms assessed at multiple time points. The study also aims to explore neuroimaging changes associated with treatment response using advanced imaging techniques. By comparing responders and non-responders, the research seeks to provide insights into the potential benefits of N2O for this population.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 60-90 with a major depressive episode who have not responded to at least one prior antidepressant treatment.
Not a fit: Patients with bipolar disorder, schizophrenia, neurodegenerative diseases, or significant unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a rapid and effective option for older adults suffering from resistant depression.
How similar studies have performed: While the use of nitrous oxide for midlife depression has shown promise, this specific application for late-life depression is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tours
- University Hospital of Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Thomas DESMIDT, MD, PhD
- Email: t.desmidt@chu-tours.fr
- Phone: 02 34 37 89 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.