drugset / Trial / NCT04957368
Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial
RandomizedParallel-groupTriple-blindOther
Summary
The purpose of the study is to investigate a short-term treatment option for major depressive disorders by administering nitrous oxide gas. At this time, the main purpose is to complete a feasibility study with 40 participants suffering from treatment-resistant depression. Participants will be randomized to (1) Study group: Nitrous oxide (inhaled) + solution of saline (injected) and the (2) Control group: Oxygen (inhaled) + Midazolam (injected) as an Active Placebo.
Timeline
- Start
- 2021-11-03
- Primary completion
- 2024-02-27
- Completion
- 2024-02-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitrous Oxide | Other / unclassified | 50 % | Inhaled |
| Comparator | Oxygen | Other / unclassified | 50 % | Inhaled |
| Comparator | Midazolam | Small molecule | 0.02 mg/kg | Intravenous |