Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT05838560
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2023-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D019588', 'term': 'Aging, Premature'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}, {'id': 'D011794', 'term': 'Quercetin'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2023-04-17', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who successfully completed and safely tolerated the intervention', 'timeFrame': '10 weeks', 'description': 'Test the safety and feasibility of dasatinib plus quercetin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Treatment Resistant Depression', 'Aging, Premature', 'Older Adults'], 'conditions': ['Schizophrenia', 'Treatment Resistant Depression', 'Aging, Premature']}, 'referencesModule': {'references': [{'pmid': '40443429', 'type': 'DERIVED', 'citation': 'Schweiger A, Diniz B, Nicol G, Schweiger J, Dasklakis-Perez AE, Lenze EJ. Protocol for a pilot clinical trial of the senolytic drug combination Dasatinib Plus Quercetin to mitigate age-related health and cognitive decline in mental disorders. F1000Res. 2025 Mar 5;13:1072. doi: 10.12688/f1000research.151963.2. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'This pilot open-label study examines the effects of a combination of dasatinib plus quercetin - two drugs that have known senolytics properties - on physiological aging in older individuals with depression or schizophrenia.', 'detailedDescription': "This is a pilot study that will enroll up to 40 participants and will examine the following:\n\n1. test the safety and feasibility of dasatinib+quercetin in two mental illnesses associated with accelerated aging: schizophrenia and treatment-resistant depression\n2. examine changes in SASP (senescence-associated secretory phenotype) with dasatinib+quercetin treatment\n3. examine acute and long-term changes in neuropsychological functioning, functional status, and brain markers of aging, as well as in clinical symptoms of the illnesses (treatment-resistant depression and schizophrenia).\n\nThis study will also combine the treatment of dasatinib plus quercetin and lifestyle-based risk factor management - which will involve the research team during the medication intervention portion to provide lifestyle education focusing on strength, balance, and nutrition. The research team will maintain close contact with participants to offer encouragement, address questions and help navigate barriers to engaging in the activities.\n\nBefore study enrollment, participants will be screened using questionnaires and a phone screen prior to being consented.\n\nThe participant will be involved for about 1 year and self-administer 8 total doses of the medications - two consecutive days of dasatinib 100mg orally plus quercetin 1250mg orally on weeks 1 (ie., 2 days on, 5 days off), 2, 3, and 4.\n\nThe participant will undergo an MRI scan at baseline and approximately week 10 of the study.\n\nBlood draws will occur at baseline, week 1, 2, 3, 4, 10, and at the endpoint. 10 ml of blood will be taken each time for 700 ml over 1 year.\n\nParticipants will have several questionnaires and assessments to complete at baseline, week 10, and the study's endpoint."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Either major depression, which is treatment-resistant (currently depressed despite at least 2 adequate trials of antidepressants in this or the previous episode), or schizophrenia/schizoaffective disorder.\n2. Age 50+ (60+ for depression).\n3. Three conditions associated with aging (e.g., hypertension/diabetes/metabolic syndrome, cardiac disease, lung disease other than asthma, cancer with adult-onset, arthritis, and inflammatory diseases typically seen in aging).\n4. No history of dementia by patient report.\n5. Already taking an adequate dose of medication for schizophrenia/schizoaffective disorder or depression.\n\nExclusion Criteria:\n\n1. Contraindications for dasatinib or quercetin\n2. Active SI such that participant could not be safely managed in an outpatient clinical trial.\n3. Taking medications that are strong CPY3A4 inhibitors or strong inducers, or that induce senescence (e.g., alkylating agents, anthracyclines, platins/other chemotherapy), or everolimus and topotecan (which have interactions with quercetin).\n4. All medications and medical conditions will be reviewed by physician study investigators to determine whether the medication or condition, in the opinion of the investigators, makes the participant inappropriate for the study. Examples of such potential excluding conditions: Active inflammatory, infectious, or malignant disease; sensory deficits that would interfere with assessments; recent heart attack or stroke; severe bleeding disorder; uncontrolled hypertension or diabetes mellitus; active liver disease or cirrhosis; current use of systemic steroids, quinolone antibiotics, hydroxychloroquine or chloroquine.'}, 'identificationModule': {'nctId': 'NCT05838560', 'briefTitle': 'Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders', 'orgStudyIdInfo': {'id': '202302203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dasatinib + quercetin', 'description': 'open label dasatinib plus quercetin combined as a drug therapy', 'interventionNames': ['Drug: Dasatinib', 'Drug: quercetin']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'otherNames': ['sprycel', 'sophoretin'], 'description': 'dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.', 'armGroupLabels': ['Dasatinib + quercetin']}, {'name': 'quercetin', 'type': 'DRUG', 'otherNames': ['quercetine', 'Vitamine P'], 'description': 'The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.', 'armGroupLabels': ['Dasatinib + quercetin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie Schweiger', 'role': 'CONTACT', 'email': 'schweigj@psychiatry.wustl.edu', 'phone': '314-362-3153'}, {'name': 'Eric Lenze, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Andes Daskalakis-Perez, BA', 'role': 'CONTACT', 'email': 'andes@wustl.edu', 'phone': '314-747-7862'}, {'name': 'Julia Schweiger', 'role': 'CONTACT', 'email': 'schweigj@wustl.edu', 'phone': '314-362-3153'}], 'overallOfficials': [{'name': 'Eric Lenze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine, Department of Psychiatry'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available by request within 1 year of the final data collection.', 'ipdSharing': 'YES', 'description': 'Deidentified data available upon request', 'accessCriteria': 'Contact study PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'UConn Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Wallace and Lucille K Renard Prof of Psychiatry', 'investigatorFullName': 'Eric Lenze', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}