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NCT05007028CompletedPhase 3

Nitrous Oxide in Resistant Depression in Elderly Subjects: A Randomized, Double-blind, Comparator Trial

Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
60 (actual)
First submitted
11 Oct 2024
Start date
16 Nov 2021
Lead sponsor
Centre Hospitalier Regional Universitaire De Tours
Diseases
Depression
NCT number
NCT05007028
EU CT number
2024-517549-15-00
EudraCT number
2019-004984-31

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 60
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • Person taking part in a clinical drug study or in a period of exclusion from any clinical study due to previous participation

Other illness

  • Bipolar disorder, schizophrenic, neurodegenerative disease documented by MINI and MMSE (non-inclusion if MMSE< 24/30), addiction to one or more toxic substances
  • 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

Other

  • 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
  • Legal incapacity and/or other circumstances rendering the patient incapable of understanding the nature, objective or consequences of the study

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceCompleted
Centre Hospitalier Universitaire de Nice
Coordinator of this site? Confirm its status
NiceFranceCompleted
Centre Hospitalier Universitaire De Rennes
Coordinator of this site? Confirm its status
Rennes Cedex 9FranceCompleted
Centre Hospitalier Regional Universitaire De Tours
Coordinator of this site? Confirm its status
Tours Cedex 9FranceCompleted

This page is information, not medical advice. Discuss any trial with your doctor.