Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders

NCT05838560 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 202302203
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Aging, Premature; Treatment Resistant Depression

Keywords

Schizophrenia; Treatment Resistant Depression; Aging, Premature; Older Adults

Outcome Measures

Primary Outcomes (1)

• Number of participants who successfully completed and safely tolerated the intervention

  Test the safety and feasibility of dasatinib plus quercetin

  10 weeks

Study Arms (1)

Dasatinib + quercetin

EXPERIMENTAL

open label dasatinib plus quercetin combined as a drug therapy

Drug: Dasatinib; Drug: quercetin

Interventions

Dasatinib DRUG

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

Also known as: sprycel, sophoretin

Dasatinib + quercetin

quercetin DRUG

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

Also known as: quercetine, Vitamine P

Dasatinib + quercetin

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• UConn Health: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 40443429 DERIVED

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Treatment-Resistant; Aging, Premature

Interventions

Dasatinib; Quercetin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Eric Lenze, MD

  Washington University School of Medicine, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 1, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available by request within 1 year of the final data collection.
• Access Criteria: Contact study PI

Locations

US (1)