Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial
- Conditions
- Treatment Resistant DepressionMajor Depressive Disorder
- Interventions
- Drug: Nitrous Oxide 99 %
- Registration Number
- NCT04957368
- Lead Sponsor
- Unity Health Toronto
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
Exclusion criteria
- Acute suicidality defined as score ≥3 on HAMD item 3
- 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
- Contraindication to receiving nitrous oxide
- Chronic cobalamin or folate deficiency
- Contraindication to receiving the placebo midazolam
- 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
- Electroconvulsive therapy within the current depressive episode
- Receiving ketamine treatment within the current depressive episode
- Unwilling to maintain current antidepressant regimen.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nitrous Oxide + saline solution Nitrous Oxide 99 % - Oxygen + Midazolam Oxygen + Midazolam -
- Primary Outcome Measures
Name Time Method Withdrawal rate 2 Years Recruitment rate 2 Years Recruitment rate
Adherence rate 2 Years Feasibility
Frequency of adverse events 2 Years Safety and tolerability
- Secondary Outcome Measures
Name Time Method Montgomery-Åsberg Depression Rating Scale (MADRAS) Score 0-60 (Higher scores represent higher depression). Measure changes in symptoms of depression 6 weeks Frequencies on numbers of 1.- Remissions (defined as MADRS score \< 10), 2.- Responses (defined as ≥ 50% reduction in MADRS score from baseline) 3.- No Responses
Toronto Side Effects Scale (TSES) - 32 items (each item has a score 1-25; higher score means higher intensity). Measure adverse side effects from antidepressant treatment 6 weeks Frequencies of safety and tolerability
Trial Locations
- Locations (1)
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada