Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants who successfully completed and safely tolerated the intervention
研究概览
简要总结
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.
详细描述
This is a pilot study that will enroll up to 40 participants and will examine the following:
- test the safety and feasibility of dasatinib+quercetin in two mental illnesses associated with accelerated aging: schizophrenia and treatment-resistant depression
- examine changes in SASP (senescence-associated secretory phenotype) with dasatinib+quercetin treatment
- 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).
This 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.
Before study enrollment, participants will be screened using questionnaires and a phone screen prior to being consented.
The 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Age 50+ (60+ for depression).
- •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).
- •No history of dementia by patient report.
- •Already taking an adequate dose of medication for schizophrenia/schizoaffective disorder or depression.
排除标准
- •Contraindications for dasatinib or quercetin
- •Active SI such that participant could not be safely managed in an outpatient clinical trial.
- •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).
- •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.
研究组 & 干预措施
Dasatinib + quercetin
open label dasatinib plus quercetin combined as a drug therapy
干预措施: Dasatinib (Drug)
Dasatinib + quercetin
open label dasatinib plus quercetin combined as a drug therapy
干预措施: quercetin (Drug)
结局指标
主要结局
Number of participants who successfully completed and safely tolerated the intervention
时间窗: 10 weeks
Test the safety and feasibility of dasatinib plus quercetin
次要结局
未报告次要终点
研究者
Eric Lenze
Wallace and Lucille K Renard Prof of Psychiatry
Washington University School of Medicine