Major Depressive Disorder
Conditions
Brief summary
This is a pilot sub-study of an ongoing trial comparing N2O to midazolam in MDD and will examine neuroimaging correlates of treatment response.
Detailed description
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.
Interventions
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.
DRUGMidazolam 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.
Sponsors
Unity Health Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain functional activity and connectivity | 4 weeks from the baseline visit | Changes in brain functional activity and connectivity between baseline and after 4 weeks of receiving the intervention, measured by MR imaging. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORVenkat Bhat, MD MSc
Unity Health Toronto
Outcome results
None listed