Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-30 @ 3:51 AM
Study NCT ID:
NCT04957368
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2021-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-07-09', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': '2 Years', 'description': 'Recruitment rate'}, {'measure': 'Withdrawal rate', 'timeFrame': '2 Years'}, {'measure': 'Adherence rate', 'timeFrame': '2 Years', 'description': 'Feasibility'}, {'measure': 'Frequency of adverse events', 'timeFrame': '2 Years', 'description': 'Safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Montgomery-Åsberg Depression Rating Scale (MADRAS) Score 0-60 (Higher scores represent higher depression). Measure changes in symptoms of depression', 'timeFrame': '6 weeks', 'description': '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'}, {'measure': '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', 'timeFrame': '6 weeks', 'description': 'Frequencies of safety and tolerability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feasibility trial', 'Nitrous Oxide'], 'conditions': ['Treatment Resistant Depression', 'Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '38241247', 'type': 'DERIVED', 'citation': 'Ladha KS, Lee J, Mattina GF, Pazmino-Canizares J, Wijeysundera DN, Gholamali Nezhad F, Philip K, Tassone VK, Adamsahib F, Bhat V; SMILE Study Investigators. Sustained Mood Improvement with Laughing Gas Exposure (SMILE): Study protocol for a randomized placebo-controlled pilot trial of nitrous oxide for treatment-resistant depression. PLoS One. 2024 Jan 19;19(1):e0297330. doi: 10.1371/journal.pone.0297330. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 episode, as defined by the Hamilton Depression Rating Scale (HAMD)\\>17\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 ≥3 on HAMD item 3\n2. Major Depressive Episode in people with Bipolar Disorder\n3. Current substance abuse or dependence and/or history of alcohol abuse or dependence within the past year\n4. Dementia\n5. Current or lifetime history of schizophrenia or schizoaffective disorder\n6. Current history of dissociative disorders\n7. Known history of hypersensitivity or allergy to Nitrous Oxide, Midazolam or any ingredients in the study formulations\n8. Contraindication to receiving nitrous oxide\n9. Chronic cobalamin or folate deficiency\n10. Contraindication to receiving the placebo midazolam\n11. 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\n12. Pregnancy or breastfeeding in female participants\n13. Electroconvulsive therapy within the current depressive episode\n14. Receiving ketamine treatment within the current depressive episode\n15. Unwilling to maintain current antidepressant regimen.'}, 'identificationModule': {'nctId': 'NCT04957368', 'acronym': 'SMILE', 'briefTitle': 'Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': '21-096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrous Oxide + saline solution', 'interventionNames': ['Drug: Nitrous Oxide 99 %']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxygen + Midazolam', 'interventionNames': ['Drug: Oxygen + Midazolam']}], 'interventions': [{'name': 'Nitrous Oxide 99 %', 'type': 'DRUG', 'description': 'Nitrous oxide will be administered at an inspiratory concentration of 50% with concurrent intravenous saline (100ml) for one hour.', 'armGroupLabels': ['Nitrous Oxide + saline solution']}, {'name': 'Oxygen + Midazolam', 'type': 'DRUG', 'description': 'Oxygen will be administered at 50% with intravenous midazolam (0.02mg/kg in 100ml) for one hour', 'armGroupLabels': ['Oxygen + Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data has been planned to be shared with other researchers at this point since this is a feasibility study with only 40 participants'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}