NCT05838560

Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a pilot study that will enroll up to 40 participants and will examine the following: 1. test the safety and feasibility of dasatinib+quercetin in two mental illnesses associated with accelerated aging: schizophrenia and treatment-resistant depression 2. examine changes in SASP (senescence-associated secretory phenotype) with dasatinib+quercetin treatment 3. 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. The participant will undergo an MRI scan at baseline and approximately week 10 of the study. Blood 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. Participants will have several questionnaires and assessments to complete at baseline, week 10, and the study's endpoint.

Conditions

• Schizophrenia
• Treatment Resistant Depression
• Aging, Premature

Interventions

Type	Name	Description
DRUG	Dasatinib	dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.
DRUG	quercetin	The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-05-01
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study