Evaluation of the Antidepressant Effects of Nitrous Oxide in People With Major Depressive Disorder
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To evaluate the acute and sustained antidepressant effects of nitrous oxide in people with major depressive disorder; and further evaluate these effects by identifying the optimal dose and regimen to guide current practice, and to plan a future large pragmatic trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Adult (≥18 years, both sexes)
• DSM-5 criteria for MDD without psychosis, as determined using a structured clinical interview \[Mini International Neuropsychiatric Interview\], MDD, defined by a pre-treatment score \>16 on the HDRS-21 scale and meeting DSM-5 for MDD
Locations
United States
Illinois
University of Chicago Medicine
RECRUITING
Chicago
Other Locations
Australia
The Alfred Hospital
RECRUITING
Melbourne
Contact Information
Primary
Frank Brown Jr
fbrown@dacc.uchicago.edu
773-834-5778
Time Frame
Start Date: 2021-06-30
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 172
Treatments
Active_comparator: Treatment; Nitrous Oxide 50% or 25%, group
Four-weekly, 60-minute inhalation sessions of 25% or 50% nitrous oxide, randomly assigned.
Placebo_comparator: Control; Oxygen-air mixture, group
Four-weekly, 60-minute inhalation sessions of an oxygen and air mixture.
Related Therapeutic Areas
Sponsors
Leads: University of Chicago
Collaborators: The Alfred