NCT03869736CompletedPhase 2
Nitrous Oxide for the Treatment of Major Depressive Disorder
Evaluation of the Antidepressant Effects of Nitrous Oxide in People With Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 16 Dec 2024
Brief summary (registry, in English)
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 that causes significant health and economic burden. Recent studies have shown that a single dose of ketamine, an NMDA-antagonist, has fast and long lasting anti-depressant effect. Nitrous oxide, another NMDA-antagonist, is widely used for anesthesia and analgesia, safer to administer and has fewer side effects than ketamine. A randomized controlled crossover feasibility study showed significant reduction in depressive symptoms at 2 and 24 hours after a single 1-hour treatment session of inhaled nitrous oxide compared with placebo. Nitrous oxide is inexpensive and can be safely administered by any trained clinician. If found to be efficacious, it could be used to provide rapid anti-depressant effect whilst the benefit of traditional anti-depressants has its delayed effect. Another potential application could be in acutely suicidal patients. This investigated-initiated phase 2b trial will enable confirmation and extension of the findings from the feasibility study, and identify the optimal dose and regimen in a broader population of those with MDD. Participants will be randomized to receive a weekly 1-hour inhalational sessions of either nitrous oxide or placebo (oxygen-air mixture) for 4 weeks, and the nitrous group will be further randomly assigned to a dose of 50% nitrous oxide or 25% nitrous oxide. Depression severity will be assessed by a blinded observer pre-treatment and at weekly intervals during and for 4 weeks after treatment using the Hamilton Depression Rating Scale.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 16 Dec 2018
- Start date
- 22 Jan 2019
- Primary completion date
- 10 Jun 2023
- Lead sponsor
- Bayside Health
- Diseases
- Depression
- NCT number
- NCT03869736
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 81
- From 22 Jan 2019 to the primary completion date, 10 Jun 2023
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Administration of NMDA-antagonists (e.g., ketamine) in previous 3 months
- Ongoing treatment with ECT
- 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).
Other illness
- 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
- Presence of acute medical illness that could interfere with study participation, including significant pulmonary disease
Other
- Active or recent (\<12 months) substance abuse or dependence; excluding nicotine
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| University of Chicago Medicine Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.