Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Aging, Premature
Depression
Depressive Disorder, Treatment-Resistant
Mental Disorders
Psychotic Disorders
Schizophrenia
Treatment Resistant Depression

Clinical Trial Details

NCT number	NCT05838560
Study type	Interventional
Source	Washington University School of Medicine
Contact	Marissa Rhea
Phone	314-362-3797
Email	marissa@wustl.edu
Status	Recruiting
Phase	Phase 2
Start date	July 1, 2023
Completion date	May 1, 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.