SchizophreniaPhase 2NCT05838560
Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders
A Phase 2 study testing Dasatinib and quercetin in people with Schizophrenia and Treatment Resistant Depression, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Schizophrenia, Treatment Resistant Depression, Aging, Premature
- What is being tested?
- Dasatinib and quercetin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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:
- 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.
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.
- Being tested
- Dasatinib, quercetin
- Keywords
- Schizophrenia, Treatment Resistant Depression, Aging, Premature, Older Adults
- Medical subject headings
- Schizophrenia, Depressive Disorder, Treatment-Resistant, Aging, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called sprycel, sophoretin
dasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.
quercetinDrug
Also called quercetine, Vitamine P
The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined.
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib + quercetin | Experimental | open label dasatinib plus quercetin combined as a drug therapy Receives: Drug: Dasatinib; Drug: quercetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who successfully completed and safely tolerated the intervention
Test the safety and feasibility of dasatinib plus quercetin
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Jul 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- UConn Health
- Responsible party
- Sponsor
- Investigators
- Eric Lenze, MD, Principal investigator, Washington University School of Medicine, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838560
- Sponsor's protocol ID
- 202302203
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data available upon request
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders
- ClinicalTrials.gov ID
- NCT05838560
- Acronym / sponsor ID
- 202302203
- Keywords
- Schizophrenia, Treatment Resistant Depression, Aging, Premature, Older Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- UConn Health
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| Dasatinib + quercetin | Experimental | Drug: Dasatinib, Drug: quercetinopen label dasatinib plus quercetin combined as a drug therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAlso: sprycel, sophoretindasatinib 100mg The intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined. | Drug | Dasatinib + quercetin |
| quercetinAlso: quercetine, Vitamine PThe intervention will involve the participant taking dasatinib 100mg and quercetin 1250ng combined. | Drug | Dasatinib + quercetin |
Primary outcome
Number of participants who successfully completed and safely tolerated the intervention
Time frame: 10 weeks
Test the safety and feasibility of dasatinib plus quercetin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 40443429Schweiger 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.
- Individual participant dataSharing planned: Yes. Deidentified data available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Lenze, MD principal investigator
Washington University School of Medicine, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib and quercetin in people with Schizophrenia and Treatment Resistant Depression, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who successfully completed and safely tolerated the intervention (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05838560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.