2024-517549-15-00CompletedPhase 3
Nitrous Oxide in Resistant Depression in Elderly Subjects: A Randomized, Double-blind, Comparator Trial
Centre Hospitalier Regional Universitaire De Tours4 sites in 1 country60 target enrollmentStarted: November 12, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- MADRS Depression Severity Scale collected collected at baseline, 2 hours, 24 hours, Week 1 and Week 2 in MEOPA vs comparator group
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
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
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 (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
Outcomes
Primary Outcomes
MADRS Depression Severity Scale collected collected at baseline, 2 hours, 24 hours, Week 1 and Week 2 in MEOPA vs comparator group
MADRS Depression Severity Scale collected collected at baseline, 2 hours, 24 hours, Week 1 and Week 2 in MEOPA vs comparator group
Secondary Outcomes
- Brain Pulsatility Indices as measured by IPT Ultrasound Imaging
- Brain volume and white matter lesion indices measured by MRI, indicators of brain atrophy and lesion load; Brain perfusion indices measured by MRI-ASL; Pulsatilité́ and Brain Connectivity indices as measured by MRI in BOLD signal
- A series of scales complementary to the MADRS for the evolution of depressive symptoms (Hamilton 17-items, CGI - Clinical Global Impression, QIDS-SR - Quick Inventory of Depressive Symptomatology Self Report)
- A series of scales for the evaluation of possible adverse effects (SSI - Scale for Suicidal Ideation, YMRS - Young Mania Rating Scale, CADSS - Clinician Administered Dissociative States Scale, BPRS - Brief Psychiatric Rating Scale)
Investigators
Thomas DESMIDT
Scientific
Centre Hospitalier Regional Universitaire De Tours
Study Sites (4)
Loading locations...
Similar Trials
Active, not recruiting
Phase 1
itrous Oxide in Resistant Depression in Elderly Subjects: A Randomized, Double-blind, Comparator TrialResistant Depression in the Elderly SubjectEUCTR2019-004984-31-FRCHRU TOURS60
Withdrawn
Phase 2
Antidepressant Effects of Nitrous OxideTreatment Resistant DepressionMajor Depressive DisorderNCT05357040University of Chicago172
Completed
Not Applicable
Nitrous Oxide for Late-Life Depression - PROTO-BRAINResistant Depression, TreatmentLate-Life DepressionNCT05007028University Hospital, Tours60
Completed
Phase 2
Nitrous Oxide for Major Depressive DisorderDepressive DisorderTreatment Resistant DepressionDepressive Disorder, MajorMajor Depressive DisorderDepressionNCT03932825Lingjiang Li44
Terminated
Early Phase 1
Nitrous TRD Bipolar DepressionTreatment- Resistant Bipolar DisorderBipolar Depressive DisorderBipolar DisorderNCT02757521Washington University School of Medicine1