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Clinical trial

Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial - Sub-Study Protocol to Include Neuroimaging

ID
Name
22-139
Description
This is a pilot sub-study of an ongoing trial comparing N2O to midazolam in MDD and will examine neuroimaging correlates of treatment response.
Trial arms
Trial start
2023-03-07
Estimated PCD
2024-08-01
Trial end
2024-12-01
Treatment
Nitrous oxide gas for inhalation
This sub-study does not have an intervention and based on the main study the participants who have received N2O will be compared with the midazolam placebo group.
Arms:
Experimental group
Other names:
Nitrous oxide at an inspiratory concentration of 50% with concurrent intravenous saline (100mL)
Midazolam injection
This sub-study does not have an intervention and based on the main study the participants who have received N2O will be compared with the midazolam placebo group.
Arms:
Placebo group
Other names:
50% oxygen with intravenous midazolam (0.02mg/kg in 100mL)
Size
20
Primary endpoint
Brain functional activity and connectivity
4 weeks from the baseline visit
Eligibility criteria
Inclusion Criteria: * Eligible for main nitrous oxide (SMILE) study Exclusion Criteria: * Contraindication for undergoing MRI scans (e.g., hip circumference \< 180 cm or metal in the body)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2024-05-06

1 organization

2 products

1 indication

Organization
Unity Health Toronto
Product
Nitrous oxide
Indication
Major Depressive Disorder
Product
Midazolam