NCT04957368CompletedPhase 4
Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
The purpose of the study is to investigate a short-term treatment option for major depressive disorders by administering nitrous oxide gas. At this time, the main purpose is to complete a feasibility study with 40 participants suffering from treatment-resistant depression. Participants will be randomized to (1) Study group: Nitrous oxide (inhaled) + solution of saline (injected) and the (2) Control group: Oxygen (inhaled) + Midazolam (injected) as an Active Placebo.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 26 Apr 2021
- Start date
- 3 Nov 2021
- Primary completion date
- 27 Feb 2024
- Lead sponsor
- Unity Health Toronto
- Diseases
- Depression
- NCT number
- NCT04957368
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 40
- From 3 Nov 2021 to the primary completion date, 27 Feb 2024
- 1 site in 1 country
- 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
- Contraindication to receiving nitrous oxide
- Contraindication to receiving the placebo midazolam
- Electroconvulsive therapy within the current depressive episode
- Receiving ketamine treatment within the current depressive episode
Other illness
- Major Depressive Episode in people with Bipolar Disorder
- Current substance abuse or dependence and/or history of alcohol abuse or dependence within the past year
- Dementia
- Current or lifetime history of schizophrenia or schizoaffective disorder
- Current history of dissociative disorders
- Known history of hypersensitivity or allergy to Nitrous Oxide, Midazolam or any ingredients in the study formulations
Other
- Acute suicidality defined as score ≥3 on HAMD item 3
- Chronic cobalamin or folate deficiency
- Use of centrally acting medicinal products, such as opioid agonists, morphine derivatives, benzodiazepines and/or other central nervous system depressants such as barbiturates and alcohol
- Pregnancy or breastfeeding in female participants
- Unwilling to maintain current antidepressant regimen.
Who the study is looking for
- 18 to 65 years of age
- Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for Major Depressive Disorder (MDD)
- Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI) for DSM-5
- Experiencing moderate to severe depressive episode, as defined by the Hamilton Depression Rating Scale (HAMD)\>17
- Failure of two trials of antidepressant therapy of adequate dose and duration, during the current depressive episode
- For women of childbearing potential, use of highly effective or double-barrier methods of contraception. Abstinence is acceptable if it is the preferred and usual lifestyle of the female participant
- Capacity to provide informed consent.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.