Status:
COMPLETED
Nitrous Oxide for the Treatment of Major Depressive Disorder
Lead Sponsor:
Bayside Health
Conditions:
Depression
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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), with DSM-IV-TR criteria for MDD without psychosis, as determined using a structured clinical interview \[Mini International Neuropsychiatric Interview\]
- MDD, as defined by a pretreatment score \>18 on the HDRS-21 scale
Exclusion
- A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
- Active or recent (\<12 months) substance abuse or dependence; 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 :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2023
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03869736
Start Date
January 22 2019
End Date
December 10 2023
Last Update
December 16 2024
Active Locations (2)
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1
University of Chicago Medicine
Chicago, Illinois, United States, 60637
2
Alfred Hospital
Melbourne, Victoria, Australia, 3004