Antidepressant Effects of Nitrous Oxide
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Major Depressive Disorder, Treatment Resistant Depression
In brief
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.
Key facts
- Study ID
- NCT05357040
- Run by
- University of Chicago
- People needed
- 0
- Starts
- 2021-06-30
- Expected to finish
- 2026-02-27
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- A current or past history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Current obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses
- Active suicidal intention, as determined by clinical interview assessment tool (Sheehan-STS) and clinical examination
- Active or recent (<12 months) substance use disorder; excluding nicotine
- Administration of NMDA-antagonists (e.g., ketamine) in previous 3 months
- Ongoing treatment with ECT
- Presence of acute medical illness that could interfere with study participation, including significant pulmonary disease
- Pregnancy or breastfeeding
- Any contraindications to the use of nitrous oxide (e.g., pneumothorax, middle ear occlusion, elevated intracranial pressure, chronic cobalamin or folate deficiency unless treated with folic acid or vitamin B12).
Where it is running
- University of Chicago Medicine — Chicago, Illinois, United States
- The Alfred Hospital — Melbourne, Victoria, Australia
Full record on ClinicalTrials.gov
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