Sustained Mood Improvement With Laughing Gas Exposure
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWomen's College Hospital
About this trial
Multi-centre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of nitrous oxide on reducing symptoms of depression in patients with treatment resistant depression.
Eligibility criteria
Qualifiers
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 episodes, as defined by the Montgomery-Åsberg Depression Rating Scale (MADRS) > 21
Disqualifiers
Acute suicidality defined as score > 4 on MADRS item 10
Diagnosis of Bipolar Disorder
Current substance abuse or dependence and/or history of alcohol abuse or dependence within the past year
Dementia
Trial design
Treatments tested in this trial
- Inhalation of Nitrous oxide (Laughing gas) + intravenous saline
- inhalation of %100 oxygen + intravenous midazolam
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Women's College Hospital
Lead sponsor
Anesthesia Clinical Trials Unit (Department of Anesthesia and Pain Management)
Collaborator
University Health Network, Toronto
Collaborator
Sunnybrook Health Sciences Centre
Collaborator
Unity Health Toronto
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov