Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-01-01 @ 12:11 AM
Study NCT ID:
NCT05007028
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2021-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitrous Oxide for Late-Life Depression - PROTO-BRAIN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000388', 'term': 'Air'}], 'ancestors': [{'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double blind trial with comparator'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2021-05-27', 'studyFirstSubmitQcDate': '2021-08-13', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MADRS', 'timeFrame': 'Baseline, 2 hours, 24 hours, 1 week, 2 weeks', 'description': 'montgomery asberg depression scale for symptoms severity'}], 'secondaryOutcomes': [{'measure': 'Change in Brain Tissue Pulsatility', 'timeFrame': 'Baseline and immediately after the intervention', 'description': 'Indexes of BTP, including BTP amplitudes'}, {'measure': 'MRI', 'timeFrame': 'At Baseline', 'description': 'Structural and Functional MRI'}, {'measure': 'Change in HDRS 17 items', 'timeFrame': 'Baseline, 2 hours, 24 hours, 1 week, 2 weeks', 'description': 'Hamilton Depression Rating Scale'}, {'measure': 'Change in QIDS-SR', 'timeFrame': 'Baseline, 2 hours, 24 hours, 1 week, 2 weeks', 'description': 'Quick Inventory of Depressive Symptomatology Self Report, Depression severity'}, {'measure': 'Change in CGI', 'timeFrame': 'Baseline, 2 hours, 24 hours, 1 week, 2 weeks', 'description': 'Clinical Global Impression'}, {'measure': 'Change in VAS', 'timeFrame': 'Baseline, 2 hours, 24 hours, 1 week, 2 weeks', 'description': 'Visual Analog Scale for global well-being self assessement'}, {'measure': 'Change in STAI', 'timeFrame': 'Baseline, 2 hours, 24 hours, 1 week, 2 weeks', 'description': 'State-Trait Anxiety Inventory'}, {'measure': 'Change in SSI', 'timeFrame': 'Baseline, 2 hours, 24 hours, 1 week, 2 weeks', 'description': 'Scale for Suicidal Ideation'}, {'measure': 'Change in YMRS', 'timeFrame': 'Baseline, 2 hours, 24 hours, 1 week, 2 weeks', 'description': 'Young Mania Rating Scale'}, {'measure': 'Change in Clinician Administered Dissociative States Scale', 'timeFrame': 'Baseline, 2 hours, 24 hours, 1 week, 2 weeks', 'description': 'CADSS'}, {'measure': 'Change in BPRS', 'timeFrame': 'Baseline, 2 hours, 24 hours, 1 week, 2 weeks', 'description': 'Brief Psychiatric Rating Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nitrous Oxide', 'Magnetic Resonance Imaging', 'Ultrasound Tissue Pulsatility Imaging'], 'conditions': ['Late-Life Depression', 'Resistant Depression, Treatment']}, 'descriptionModule': {'briefSummary': 'Resistant Depression is a common condition in older adults and there is an urgent need for novel antidepressant in this population. Nitrous Oxide (N2O) has recently shown rapid antidepressant effect in midlife depression but no study has currently investigated the efficacy and safety of N2O in Late-Life Depression (LLD), while N2O may prove to be an ideal treatment for LLD because of glutamatergic antagonism and cerebrovascular effects and also a relatively good safety profile.\n\nThe goal of our study is to compare changes in depressive symptoms after 2 hours, 24 hours, 1 week and 2 week of a 1-hour exposure to EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) versus Medical Air.\n\nSecondary Objectives include comparing differences in neuroimaging measures between 3 groups (responders and non-responders in the EMONO group, and patients in the control group).', 'detailedDescription': 'Secondary objectives include:\n\n* To compare changes in Brain Tissue Pulsatility (BTP) as measured with Ultrasound Tissue Pulsatility Imaging (TPI) between responders in the EMONO group (MADRS change of at least 50%), non-responders in the EMONO group (MADRS change of no more than 50%) and in the Air Medical group\n* To compare baseline differences in structural (brain volumes, white matter hyperintensities) and functional (resting state connectivity in BOLD, Brain Pulsatility in BOLD, Brain Perfusion in ASL) among the 3 groups\n* To compare changes in depressive and anxiety symptoms between the active and control group, as assess with Hamilton scale, CGI scale, QIDS-SR, VAS and the STAI scale\n* To compare safety between the active and control group, as assessed with SSI, YMRS, CADSS, BPRS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 60-90 years-old\n* Major Depressive Episode according to DSM-5 criteria, confirmed by the MINI - Mini International Neuropsychiatric Interview\n* MADRS score greater than 20 (Montgomery Asberg Depression Rating Scale)\n* Patient resistant to at least one well-conducted antidepressant treatment, as documented by the MGH-ATRQ scale\n* Patient who can undergo N2O diffusion via a facial mask\n* Patient who has signed an informed consent\n* Person affiliated with a social security scheme\n\nExclusion Criteria:\n\n* Bipolar disorder, schizophrenic disorder, neurodegenerative disease, documented by the MINI and the MMSE (non-inclusion if MMSE \\< 24/30), addictive disorder\n* Unstable somatic pathology (including unstable neurological or cardiological diseases at risk of interfering with N2O diffusion)\n* Presence of active and significant psychotic symptoms, at investigator's discretion\n* Contraindications to EMONO (50%N2O/ 50%O2) : pneumothorax, emphysema, bowel obstruction, intracranial hypertension, chronic deficiency in vitamin B12 or B9\n* Contraindications to MRI, including claustrophobia\n* Legal incapacity and/or other circumstances unabling the patient to understand the nature, purpose or consequences of the study\n* A person participating in a drug clinical trial or during a period of exclusion from any clinical study"}, 'identificationModule': {'nctId': 'NCT05007028', 'acronym': 'PROTO-BRAIN', 'briefTitle': 'Nitrous Oxide for Late-Life Depression - PROTO-BRAIN', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Nitrous Oxide for Late-Life Depression : a Randomized Controlled Trial With Comparator - PROTO-BRAIN', 'orgStudyIdInfo': {'id': 'DR180133'}, 'secondaryIdInfos': [{'id': '2019-002769-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrous Oxide', 'description': 'Active Drug: EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide)', 'interventionNames': ['Drug: EMONO']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Medical air', 'description': 'Control Drug: Medical air : 78% N2 / 22% O2', 'interventionNames': ['Drug: Medical Air']}], 'interventions': [{'name': 'EMONO', 'type': 'DRUG', 'description': 'Exposure to 1 hour of EMONO via facial mask', 'armGroupLabels': ['Nitrous Oxide']}, {'name': 'Medical Air', 'type': 'DRUG', 'description': 'Exposure to 1 hour of Medical Air via facial mask', 'armGroupLabels': ['Medical air']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'University Hospital of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}