Status:
RECRUITING
Antidepressant Effects of Nitrous Oxide
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
The Alfred
Conditions:
Major Depressive Disorder
Treatment Resistant Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
The investigators are conducting a randomized controlled trial to evaluate the antidepressant effects of nitrous oxide in people with Major Depressive Disorder (MDD). MDD is a global medical condition...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT05357040
Start Date
June 30 2021
End Date
December 1 2026
Last Update
October 7 2025
Active Locations (2)
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1
University of Chicago Medicine
Chicago, Illinois, United States, 60637
2
The Alfred Hospital
Melbourne, Victoria, Australia, 3004