Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT05294835
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2022-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketamine and Epigenetic Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related 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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective, single arm'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epigenetic Age', 'timeFrame': 'Biological age will be compared from baseline to study completion, an average of five weeks', 'description': 'DNA Methylation-derived epigenetic age'}], 'secondaryOutcomes': [{'measure': 'Severity of Illness and baseline epigenetic age', 'timeFrame': 'Assessment will evaluate the correlation of data collected at baseline with data from after treatment is completed, on average five weeks', 'description': 'Assess if severity of illness prior to treatment is associated with biological age before treatment'}, {'measure': 'Severity of Illness and post-treatment epigenetic age', 'timeFrame': 'Assessment will evaluate the correlation of data collected at baseline with biological age assessed after treatment is complete, on average five weeks', 'description': 'Assess if severity of illness, as measured by PHQ-9 (Patient Health Questionnaire-9) or PCL-5 (PTSD Checklist for DSM 5) prior to treatment is associated with biological age after treatment'}, {'measure': 'Degree of Treatment Response', 'timeFrame': 'Assessment will compare the difference in PHQ-9/PCL-5 scores from baseline to after treatment with change in biological age from baseline to post-treartment.', 'description': 'Assess if degree of treatment response to ketamine infusion, as measured by PHQ-9 (Patient Health Questionnaire-9) or PCL-5 (PTSD Checklist for DSM 5), is associated with change in biological age'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Post Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '29656664', 'type': 'BACKGROUND', 'citation': 'Han LKM, Aghajani M, Clark SL, Chan RF, Hattab MW, Shabalin AA, Zhao M, Kumar G, Xie LY, Jansen R, Milaneschi Y, Dean B, Aberg KA, van den Oord EJCG, Penninx BWJH. Epigenetic Aging in Major Depressive Disorder. Am J Psychiatry. 2018 Aug 1;175(8):774-782. doi: 10.1176/appi.ajp.2018.17060595. Epub 2018 Apr 16.'}, {'pmid': '33065824', 'type': 'BACKGROUND', 'citation': 'Marcantoni WS, Akoumba BS, Wassef M, Mayrand J, Lai H, Richard-Devantoy S, Beauchamp S. A systematic review and meta-analysis of the efficacy of intravenous ketamine infusion for treatment resistant depression: January 2009 - January 2019. J Affect Disord. 2020 Dec 1;277:831-841. doi: 10.1016/j.jad.2020.09.007. Epub 2020 Sep 7.'}, {'pmid': '41173838', 'type': 'DERIVED', 'citation': 'Dawson KL, Carangan AMJM, Klunder J, Carreras-Gallo N, Sehgal R, Megilligan S, Askins BC, Perkins N, Mendez TL, Smith RM, Dawson MS, Mallin MP, Higgins-Chen AT, Dwaraka VB. Epigenetic aging and DNA methylation biomarker changes following ketamine treatment in patients with MDD and PTSD: a pilot study. Transl Psychiatry. 2025 Oct 31;15(1):452. doi: 10.1038/s41398-025-03683-y.'}], 'seeAlsoLinks': [{'url': 'https://www.nature.com/articles/s41398-021-01302-0', 'label': '"GrimAge," an epigenetic predictor of mortality, is accelerated in major depressive disorder'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, clinical pilot study (n=20) to evaluate the impact of a ketamine treatment for Major Depressive Disorder (MDD) or Post Traumatic Stress Disorder (PTSD) on epigenetic aging by the TruAge epigenetic age laboratory test.', 'detailedDescription': 'Subjects with MDD or PTSD will have a series of six ketamine infusions over two to three weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be 18-64 years old of any sex, gender orientation, and ethnicity\n* Read, understand, and provide written informed consent in English,\n* Meet criteria for a primary psychiatric diagnosis of Major Depressive Disorder (MDD) or Post-traumatic Stress Disorder (PTSD) for greater than 4 weeks,\n* Have a history of at least 1 failed medication trial targeting MDD or PTSD\n* Have a reliable form of transportation to lodging or home following the completion of each ketamine infusion treatment day,\n* Be generally healthy, as assessed by medical history, physical examination (including vital signs), and clinical laboratory evaluations,\n* Be of non-childbearing potential or utilizing an acceptable form of birth control (females-only)\n* Report a pre-treatment symptom level of ≧15 on the PHQ-9 or ≧ 33 on the PCL-5\n* Consent to participation in venipuncture, drug test, pregnancy test (for females) psychiatric evaluation, rating scale completion and ketamine infusion treatment series of six over the course of two to three weeks.\n\nExclusion Criteria:\n\n* Delirium or dementia diagnosis,\n* Unstable medical illness or clinically significant laboratory results,\n* History of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at high risk for possible cardiac side effects, or uncontrolled hypertension\n* History of multiple adverse drug reactions,\n* Current or past history of psychotic disorder or psychotic symptoms,\n* Current manic symptoms,\n* Active substance use disorders with the exception of nicotine and caffeine, within the past six months or any past history of ketamine or PCP abuse,\n* Requirement of excluded medications that interact with ketamine,\n* Pregnancy, breastfeeding or unacceptable means of birth control in a female of child-bearing age,\n* Current acute suicidal or homicidal risk,\n* Previous exposure to ketamine'}, 'identificationModule': {'nctId': 'NCT05294835', 'briefTitle': 'Ketamine and Epigenetic Aging', 'organization': {'class': 'INDUSTRY', 'fullName': 'TruDiagnostic'}, 'officialTitle': 'Impact of Ketamine on Epigenetic Age (IKEA)', 'orgStudyIdInfo': {'id': 'TD-WH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine Infusion', 'description': 'subanesthetic ketamine infusion (0.5mg/kg) over 2-3 weeks', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'ketamine infusion', 'armGroupLabels': ['Ketamine Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Klunder', 'role': 'CONTACT', 'email': 'jessica.klunder@wildhealth.com', 'phone': '615-278-6394'}, {'name': 'Mike Mallin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wild Health', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Jessica Klunder', 'role': 'CONTACT', 'email': 'jessica.klunder@wildhealth.com', 'phone': '(615) 278-6394'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TruDiagnostic', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Wild Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}