Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:47 PM
Study NCT ID:
NCT07307768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-29
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine Biomarker Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale (HDRS) 22', 'timeFrame': 'Baseline, Hour 1, Hour 4, Hour 24, and Hour 72', 'description': 'Twenty-two question Depression rating scale (excluding the two questions on weight loss and diurnal variation)'}], 'secondaryOutcomes': [{'measure': 'The Columbia Suicidality Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline, Hour 1, Hour 4, Hour 24, and Hour 72', 'description': 'A semi-structured, investigator-rated interview assessing both suicidal behavior and suicidal ideation.'}, {'measure': 'The Clinician Administered Dissociative States Scale (CADSS)', 'timeFrame': 'Baseline, and Hour 1', 'description': 'A scale that rates dissociative symptoms with a 27-item scale, rated 0-4, 19 subjective, and 8 observer items'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Baseline and Hour 24', 'description': 'A ten-item diagnostic used for the assessment of depression severity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketamine', 'EEG', 'Depression', 'MDD', 'unipolar Depression', 'Biomarker'], 'conditions': ['Treatment Resistant Depression (TRD)']}, 'descriptionModule': {'briefSummary': 'We will be developing an EEG-based biomarker for the effects of ketamine infusion in patients with Depression. We will be analyzing the effects of ketamine infusion on Depression symptoms and EEG signals.', 'detailedDescription': 'This trial is a biomarker development study. We will be examining the effects of various doses of ketamine infusion on depressive symptoms and EEG signals in patients with unipolar depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physically healthy patients who meet DMS-5 criteria for a major depressive episode (MDE) in the context of MDD and who score at least 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS)\n* If taking antidepressants, dose is stable for at least 6 weeks.\n\nExclusion Criteria:\n\n* Lifetime history of bipolar disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder, including MDD with psychotic features\n* A first-degree relative with bipolar disorder, schizoaffective disorder, or schizophrenia, with the potential participant younger than 33 years (i.e., still at age of risk for a psychotic disorder)\n* Receipt of electroconvulsive therapy within 3 months of enrolling in the study\n* History of IV drug use\n* Nonresponse or intolerance to ketamine administered either clinically or as part of a prior research study\n* Pregnancy, planning to conceive, or sexually active but not using adequate birth control.\n* Actively suicidal (CSSRS≥3)\n* No antipsychotics or medications (e.g. benzodiazepines, anti-epileptics) that are likely to interact with GABA or glutamate,'}, 'identificationModule': {'nctId': 'NCT07307768', 'briefTitle': 'Ketamine Biomarker Validation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Soterix Medical'}, 'officialTitle': 'EEG Biomarker Development for Ketamine Administration', 'orgStudyIdInfo': {'id': 'KETAEEG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low level ketamine', 'description': '0.25 mg/kg ketamine infusion', 'interventionNames': ['Drug: Ketamine (0.25 mg/kg)']}, {'type': 'EXPERIMENTAL', 'label': 'Medium level ketamine', 'description': '0.5 mg/kg ketamine infusion', 'interventionNames': ['Drug: Ketamine (0.5 mg/kg)']}, {'type': 'EXPERIMENTAL', 'label': 'High level ketamine', 'description': '0.75 mg/kg ketamine infusion', 'interventionNames': ['Drug: Ketamine (0.75 mg/kg)']}], 'interventions': [{'name': 'Ketamine (0.25 mg/kg)', 'type': 'DRUG', 'description': 'Low level ketamine infusion therapy.', 'armGroupLabels': ['Low level ketamine']}, {'name': 'Ketamine (0.5 mg/kg)', 'type': 'DRUG', 'description': 'Medium level ketamine infusion therapy.', 'armGroupLabels': ['Medium level ketamine']}, {'name': 'Ketamine (0.75 mg/kg)', 'type': 'DRUG', 'description': 'High level ketamine infusion therapy.', 'armGroupLabels': ['High level ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Yishai Valter, MS', 'role': 'CONTACT', 'email': 'trials@soterixmedical.com', 'phone': '8889908327'}], 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Yishai Valter, MS', 'role': 'CONTACT', 'email': 'trials@soterixmedical.com', 'phone': '8889908327'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soterix Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Columbia University Irving Medical Center, New York, NY', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}