SMILE Trial - Imaging Sub-Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-07

Study Completion Date

2024-06-14

Brief Summary

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This is a pilot sub-study of an ongoing trial comparing N2O to midazolam in MDD and will examine neuroimaging correlates of treatment response.

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Detailed Description

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Magnetic resonance imaging (MRI) scans of MDD-affected brains have revealed changes in structural and functional connectivity compared to healthy subjects. This pilot sub-study examines structural and functional connectivity associated with MDD-affected patient participants' responsiveness to N2O compared to the midazolam placebo, which induces similar sedative effects. The investigators intend to address the changes in brain functional activity and connectivity between baseline and after a four-week intervention course involving weekly nitrous oxide inhalations measured by MRI.

Conditions

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Major Depressive Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

Participants assigned to this intervention arm in the main study will have been administered nitrous oxide at an inspiratory concentration of 50% with concurrent intravenous saline (100mL) for one hour.

Nitrous oxide gas for inhalation

Intervention Type DRUG

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.

Placebo group

Participants assigned to this intervention arm in the main study will have been administered 50% oxygen with intravenous midazolam (0.02mg/kg in 100mL) for one hour.

Midazolam injection

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Nitrous oxide at an inspiratory concentration of 50% with concurrent intravenous saline (100mL) 50% oxygen with intravenous midazolam (0.02mg/kg in 100mL)