[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613086":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":88,"collaborators":91,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":48,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":48,"overallStatus":124,"whyStopped":48,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Women's College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Nitrous oxide+ intravenous Saline",[13],"Drug: Inhalation of Nitrous oxide (Laughing gas) + intravenous saline",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Control Group","ACTIVE_COMPARATOR","100% oxygen+ intravenous midazolam",[19],"Drug: inhalation of %100 oxygen + intravenous midazolam",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Inhalation of Nitrous oxide (Laughing gas) + intravenous saline","Nitrous oxide at an inspiratory concentration of 50% with concurrent intravenous saline (20ml) for one hour.",[9],[27],"Nitrous oxide",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"inhalation of %100 oxygen + intravenous midazolam","Inspiration of 100% oxygen with concurrent intravenous midazolam (0.02mg\u002Fkg, up to 2 mg) for one hour.",[15],[33],"Midazolam",[35],{"name":36,"affiliation":5,"role":37},"Karim Ladha, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Anesthesia Clinical Trials Unit","CONTACT","416-340-4800","4221","actu@uhn.ca",[46,60,66,72,82],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":48},"Sunnybrook Health Sciences Centre",null,"Toronto","Ontario","M4N 3M5","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-79.39864,43.70643,{"lat":58,"lon":57},{"facility":61,"status":48,"city":49,"state":50,"zip":62,"country":52,"countryCode":53,"cosmosGeoPoint":63,"geoPoint":65,"contacts":48},"St. Michael's Hospital (Unity Health)","M5B 1W8",{"type":55,"coordinates":64},[57,58],{"lat":58,"lon":57},{"facility":67,"status":48,"city":49,"state":50,"zip":68,"country":52,"countryCode":53,"cosmosGeoPoint":69,"geoPoint":71,"contacts":48},"Toronto General Hospital (UHN)","M5G 2C4",{"type":55,"coordinates":70},[57,58],{"lat":58,"lon":57},{"facility":5,"status":48,"city":49,"state":50,"zip":73,"country":52,"countryCode":53,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"M5S 1B2",{"type":55,"coordinates":75},[57,58],{"lat":58,"lon":57},[78],{"name":79,"role":41,"phone":80,"phoneExt":48,"email":81},"Didem Bozak","4163236008","didem.bozak@wchospital.ca",{"facility":83,"status":48,"city":49,"state":50,"zip":84,"country":52,"countryCode":53,"cosmosGeoPoint":85,"geoPoint":87,"contacts":48},"Toronto Western Hospital (UHN)","M5T 2S8",{"type":55,"coordinates":86},[57,58],{"lat":58,"lon":57},{"type":37,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Karim Ladha","MD MSc FRCPC",[92,95,97,98,100],{"name":93,"class":94},"Anesthesia Clinical Trials Unit (Department of Anesthesia and Pain Management)","UNKNOWN",{"name":96,"class":6},"University Health Network, Toronto",{"name":47,"class":6},{"name":99,"class":6},"Unity Health Toronto",{"name":101,"class":102},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100613086","phase-3-sustained-mood-improvement-with-laughing-gas-exposure-100613086",false,"NCT07262008","Sustained Mood Improvement With Laughing Gas Exposure","Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Double-Blind Trial","SMILE","Inclusion Criteria:\n\n1. 18 to 65 years of age\n2. Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for Major Depressive Disorder (MDD)\n3. Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI) for DSM-5\n4. Experiencing moderate to severe depressive episodes, as defined by the Montgomery-Åsberg Depression Rating Scale (MADRS) \\> 21\n5. Failure of two trials of antidepressant therapy of adequate dose and duration, during the current depressive episode\n6. 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\n7. Capacity to provide informed consent.\n\nExclusion Criteria:\n\n1. Acute suicidality defined as score \\> 4 on MADRS item 10\n2. Diagnosis of Bipolar Disorder\n3. Current substance abuse or dependence and\u002For history of alcohol abuse or dependence within the past year\n4. Dementia\n5. Current or lifetime history of schizophrenia or schizoaffective disorder\n6. Known history of hypersensitivity or allergy to nitrous oxide, midazolam or any ingredients in the study formulations\n7. Contraindication to receiving nitrous oxide (e.g. any condition where air is entrapped within a body and its expansion might be dangerous such as, pneumothorax, elevated intracranial pressure, air embolism, recent middle ear, vitreoretinal or bowel obstruction surgeries, etc.)\n8. Known chronic cobalamin or folate deficiency (e.g. signs of anemia or neurological symptoms, with plasma levels of homocysteine over 15 µmol\u002FL and abnormal red blood cells and leukocytes on a complete blood count CBC) or current methotrexate use\n9. Contraindication to receiving the placebo midazolam (e.g. shock, chronic heart failure, chronic obstructive pulmonary disease, closed-angle glaucoma, renal failure, patients with limited pulmonary reserve or those with severe decline of vital signs)\n10. Daily use of centrally acting medicinal products, such as opioid agonists, (e.g. naloxone and naltrexone) morphine derivatives (e.g. oxycodone, hydrocodone, oxymorphone, codeine), benzodiazepines (e.g. diazepam, clonazepam, alprazolam) and\u002For other central nervous system depressants such as barbiturates (e.g. phenobarbital, pentobarbital, amobarbital) and alcohol within the past week.\n11. Pregnancy or breastfeeding\n12. Received electroconvulsive therapy within the past six months\n13. Received ketamine treatment within the past six months\n14. Received repetitive transcranial magnetic stimulation within the past six months\n15. Unwilling to maintain current antidepressant regimen.","ALL","18 Years","65 Years",{"count":115,"type":116},120,"ESTIMATED","INTERVENTIONAL",[119],"PHASE3","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.",[122,123],"Major Depressive Disorder","Treatment Resistant Depression","NOT_YET_RECRUITING","2025-12-03",{"date":127,"type":128},"2025-12-10","ACTUAL",{"date":130,"type":116},"2026-02-01",{"date":132,"type":116},"2028-09-01",{"name":5,"class":6},5]