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Active, not recruitingNCT05838560Updated Apr 21, 2026

Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders

A Phase 2 interventional study of Dasatinib and quercetin in Schizophrenia, Treatment Resistant Depression and Aging, Premature, sponsored by Washington University School of Medicine. Active, not recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schizophrenia
  • Treatment Resistant Depression
  • Aging, Premature

Keywords

  • Schizophrenia
  • Treatment Resistant Depression
  • Aging, Premature
  • Older Adults
03

In context

Schizophrenia

3,472 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 2,873 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,764 studies on the registry; 270 are open to participants now.

Of its 325 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Age 50+ (60+ for depression).
  3. 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).
  4. No history of dementia by patient report.
  5. Already taking an adequate dose of medication for schizophrenia/schizoaffective disorder or depression.

Exclusion criteria

Exclusion Criteria:

  1. Contraindications for dasatinib or quercetin
  2. Active SI such that participant could not be safely managed in an outpatient clinical trial.
  3. 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).
  4. 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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Dasatinib + quercetin

    open label dasatinib plus quercetin combined as a drug therapy

    Drug: Dasatinib · Drug: quercetin

Interventions

  • DrugDasatinib

    dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.

    Also known as: sprycel, sophoretin

  • Drugquercetin

    The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.

    Also known as: quercetine, Vitamine P

06

What researchers measure

Primary outcomes

  1. Number of participants who successfully completed and safely tolerated the intervention

    Test the safety and feasibility of dasatinib plus quercetin

    Time frame: 10 weeks

07

Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
08

References and documents

Publications

  • 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. PubMed 40443429 ↗

Individual participant data

Plan to share: Yes — Deidentified data available upon request

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05838560
Lead sponsor
Washington University School of Medicine
Collaborators
UConn Health
Responsible party
Sponsor
First posted
May 1, 2023
Start date
Jul 1, 2023
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Apr 21, 2026

Study contacts

Eric Lenze, MD
principal investigator · Washington University School of Medicine, Department of Psychiatry

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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