Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:34 AM
Study NCT ID:
NCT07399756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mitochondrial Function After Ketamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'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': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Mitochondrial DNA (mtDNA) copy number will be assessed using quantitative real-time PCR (RT-qPCR) from DNA isolated from PBMCs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'mitochondrial function as a biomarker for S-ketamine treatment', 'timeFrame': '3 hours and 6 weeks', 'description': 'Can changes in mitochondrial function serve as biomarkers for predicting or monitoring clinical response to S-ketamine treatment'}], 'primaryOutcomes': [{'measure': 'S-ketamine effects on the mitochondrial', 'timeFrame': '3 hours and 6 weeks', 'description': 'Does S-ketamine treatment modulate mitochondrial function in peripheral blood cells, as reflected by mitochondrial content and circulating mitochondrial biomarkers such as GDF15?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ketamine, Mitochondrial, Treatment-Resistant Depression'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the role of mitochondria in response to S-ketamine. in individuals with Treatment-Resistant Depression.\n\nthe Research Questions are\n\n1. Does S-ketamine treatment modulate mitochondrial function in peripheral blood cells, as reflected by mitochondrial content and circulating mitochondrial biomarkers such as GDF15?\n2. Can changes in mitochondrial function serve as biomarkers for predicting or monitoring clinical response to S-ketamine treatment?\n\nSamples will be collected at baseline, 3 hours after the first treatment, and 6 weeks post-exposure, and compared between responders and non-responders'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will recruit ten normal controls, 30 Patients with the diagnosis of treatment-resistant depression (TRD), failed to at least two antidepressants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale or female, 18-65 years of age Diagnosis of Major Depressive Disorder according to the DSM-V Patient has a HAM-D≥23 Treatment resistant -Did not respond to two antidepressants trial Medically stable: No active physical disease: malignancy, cardiac condition, hypertension , stable medications for the past month etc.\n\nExclusion Criteria:\n\nKnown sensitivity to ketamine drug or alcohol abuse Patient taking lithium or corticosteroids Pregnant or breast-feeding has another axis I diagnosis attention deficits disorder a history or current serious neurological, metabolic autoimmune bone marrow, oncologic or additional psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT07399756', 'briefTitle': 'Mitochondrial Function After Ketamine', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Assessment of Mitochondrial Parameters in Blood Before and After S-Ketamine Treatment', 'orgStudyIdInfo': {'id': 'SHEBA-05-2419-RA-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ketamine inhalation group', 'description': 'Treatment-Resistant Depression patient after Ketamine inhalation', 'interventionNames': ['Drug: S (+) Ketamine']}], 'interventions': [{'name': 'S (+) Ketamine', 'type': 'DRUG', 'description': 'the patients are treated with S-Ketamine in order to treat there Treatment-Resistant Depression via inhalation', 'armGroupLabels': ['Ketamine inhalation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'state': 'Israel', 'country': 'Israel', 'contacts': [{'name': 'tzur mayer, dr', 'role': 'CONTACT', 'email': 'tzur.mayer@sheba.health.gov.il', 'phone': '972 035303318'}, {'name': 'revital amiaz, dr', 'role': 'CONTACT', 'email': 'revital.amiaz@sheba.health.gov.il', 'phone': '972035302538'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'revital amiaz, dr', 'role': 'CONTACT', 'email': 'revital.amiaz@sheba.health.gov.il', 'phone': '972 035302538'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}