Using nitrous oxide to treat major depressive disorder
Evaluation of the Antidepressant Effects of Nitrous Oxide in People With Major Depressive Disorder
This study is testing if nitrous oxide can help adults with major depression who haven't found relief from other treatments feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05357040 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the antidepressant effects of nitrous oxide in adults with Major Depressive Disorder (MDD), particularly those who have not responded to traditional treatments. Participants will be randomly assigned to receive either nitrous oxide or a placebo during weekly 1-hour inhalation sessions over four weeks. The study aims to identify the optimal dose and regimen of nitrous oxide to enhance its efficacy and guide future larger trials. The research builds on previous findings that suggest nitrous oxide may provide rapid relief from depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with Major Depressive Disorder without psychosis.
Not a fit: Patients with a history of bipolar disorder, schizophrenia, or active suicidal intentions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a rapid and effective option for patients suffering from major depressive disorder, especially those resistant to conventional therapies.
How similar studies have performed: Previous studies have shown promising results with nitrous oxide for depression, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult (≥18 years, both sexes) 2. 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 Exclusion Criteria: 1. A current or past history of bipolar disorder, schizophrenia, or schizoaffective disorder. 2. Current obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses 3. Active suicidal intention, as determined by clinical interview assessment tool (Sheehan-STS) and clinical examination 4. Active or recent (\<12 months) substance use disorder; excluding nicotine 5. Administration of NMDA-antagonists (e.g., ketamine) in previous 3 months 6. Ongoing treatment with ECT 7. Presence of acute medical illness that could interfere with study participation, including significant pulmonary disease 8. Pregnancy or breastfeeding 9. 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 this trial is running
Chicago, Illinois and 1 other locations
- University of Chicago Medicine — Chicago, Illinois, United States (Recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Peter Nagele, MD, MSc — University of Chicago, Department of Anesthesia and Critical Care
- Study coordinator: Frank Brown Jr
- Email: fbrown@dacc.uchicago.edu
- Phone: 773-834-5778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.