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Nitrous Oxide in Resistant Depression in Elderly Subjects: A Randomized, Double-blind, Comparator Trial
EU CTIS ID: 2024-517549-15-00
What this study is testing
To compare changes in depressive symptomatology at 2 hours, 24 hours, Week 1 and Week 2 of exposure to MEOPA versus medical air, in a population of elderly subjects with a characterized depressive episode meeting the criteria for resistant depression and treated with antidepressants.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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 (in particular unstable neurological or cardiological pathologies at risk of interfering with the diffusion of MEOPA) and any unexplained recent neurological abnormality
- Presence of active and significant psychotic symptoms, at the discretion of the investigator
- Contraindications to the use of MEOPA and any condition where air is trapped́ inside the body and its expansion could be dangerous: Pneumothorax, emphysema, intestinal obstruction, intracranial hypertension, known and unsubstituted vitamin B12 or B9 deficiency (based on a dosage less than 1 month old), Patients requiring oxygen ventilation; Any alteration in the state of consciousness, preventing patient cooperation; Head trauma; Gas embolism; Diving accident; Abdominal gas distension; Patient who has recently received an ophthalmic gas (SF6, C3F8, C2F6) used in eye surgery (as long as a gas bubble persists inside the eye and for at least 3 months)
- Contraindications to MRI, including claustrophobia, a metallic foreign body in the eye, pacemaker, neurostimulator, cochlear implants (or non-removable electronic medical equipment), old-generation heart valves, vascular clips formerly implanted on a cranial aneurysm
- Legal incapacity and/or other circumstances rendering the patient incapable of understanding the nature, objective or consequences of the study
See the full eligibility 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
- 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 (in particular unstable neurological or cardiological pathologies at risk of interfering with the diffusion of MEOPA) and any unexplained recent neurological abnormality
- Presence of active and significant psychotic symptoms, at the discretion of the investigator
- Contraindications to the use of MEOPA and any condition where air is trapped́ inside the body and its expansion could be dangerous: Pneumothorax, emphysema, intestinal obstruction, intracranial hypertension, known and unsubstituted vitamin B12 or B9 deficiency (based on a dosage less than 1 month old), Patients requiring oxygen ventilation; Any alteration in the state of consciousness, preventing patient cooperation; Head trauma; Gas embolism; Diving accident; Abdominal gas distension; Patient who has recently received an ophthalmic gas (SF6, C3F8, C2F6) used in eye surgery (as long as a gas bubble persists inside the eye and for at least 3 months)
- Contraindications to MRI, including claustrophobia, a metallic foreign body in the eye, pacemaker, neurostimulator, cochlear implants (or non-removable electronic medical equipment), old-generation heart valves, vascular clips formerly implanted on a cranial aneurysm
- Legal incapacity and/or other circumstances rendering the patient incapable of understanding the nature, objective or consequences of the study
- Person taking part in a clinical drug study or in a period of exclusion from any clinical study due to previous participation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.