DepressionPhase 2NCT05294835
Ketamine and Epigenetic Aging
A Phase 2 study testing Ketamine in people with Depression and Post Traumatic Stress Disorder, run by TruDiagnostic at 1 site in United States.
Trial summary
This is a prospective, clinical pilot study (n=20) to evaluate the impact of a ketamine treatment for Major Depressive Disorder (MDD) or Post Traumatic Stress Disorder (PTSD) on epigenetic aging by the TruAge epigenetic age laboratory test. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Post Traumatic Stress Disorder
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be 18-64 years old of any sex, gender orientation, and ethnicity
- Read, understand, and provide written informed consent in English,
- Meet criteria for a primary psychiatric diagnosis of Major Depressive Disorder (MDD) or Post-traumatic Stress Disorder (PTSD) for greater than 4 weeks,
- Have a history of at least 1 failed medication trial targeting MDD or PTSD
- Have a reliable form of transportation to lodging or home following the completion of each ketamine infusion treatment day,
- Be generally healthy, as assessed by medical history, physical examination (including vital signs), and clinical laboratory evaluations,
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- Be of non-childbearing potential or utilizing an acceptable form of birth control (females-only)
- Report a pre-treatment symptom level of ≧15 on the PHQ-9 or ≧ 33 on the PCL-5
- Consent to participation in venipuncture, drug test, pregnancy test (for females) psychiatric evaluation, rating scale completion and ketamine infusion treatment series of six over the course of two to three weeks.
Who cannot join
- Delirium or dementia diagnosis,
- Unstable medical illness or clinically significant laboratory results,
- History of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at high risk for possible cardiac side effects, or uncontrolled hypertension
- History of multiple adverse drug reactions,
- Current or past history of psychotic disorder or psychotic symptoms,
- Current manic symptoms,
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- Active substance use disorders with the exception of nicotine and caffeine, within the past six months or any past history of ketamine or PCP abuse,
- Requirement of excluded medications that interact with ketamine,
- Pregnancy, breastfeeding or unacceptable means of birth control in a female of child-bearing age,
- Current acute suicidal or homicidal risk,
- Previous exposure to ketamine
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wild Health
Lexington, Kentucky, 40503
Jessica Klunder, 615-278-6394, jessica.klunder@wildhealth.com
Mike Mallin, MD
About this study
Official title: Impact of Ketamine on Epigenetic Age (IKEA)
This is a prospective, clinical pilot study (n=20) to evaluate the impact of a ketamine treatment for Major Depressive Disorder (MDD) or Post Traumatic Stress Disorder (PTSD) on epigenetic aging by the TruAge epigenetic age laboratory test.
Read the detailed description
Subjects with MDD or PTSD will have a series of six ketamine infusions over two to three weeks.
- Conditions
- Depression, Post Traumatic Stress Disorder
- Being tested
- Ketamine
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
ketamine infusion
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Infusion | Experimental | subanesthetic ketamine infusion (0.5mg/kg) over 2-3 weeks Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic Age
DNA Methylation-derived epigenetic age
Measured: Biological age will be compared from baseline to study completion, an average of five weeks
Secondary outcomes (3)
Severity of Illness and baseline epigenetic age
Assess if severity of illness prior to treatment is associated with biological age before treatment
Measured: Assessment will evaluate the correlation of data collected at baseline with data from after treatment is completed, on average five weeks
Severity of Illness and post-treatment epigenetic age
Assess if severity of illness, as measured by PHQ-9 (Patient Health Questionnaire-9) or PCL-5 (PTSD Checklist for DSM 5) prior to treatment is associated with biological age after treatment
Measured: Assessment will evaluate the correlation of data collected at baseline with biological age assessed after treatment is complete, on average five weeks
Degree of Treatment Response
Assess if degree of treatment response to ketamine infusion, as measured by PHQ-9 (Patient Health Questionnaire-9) or PCL-5 (PTSD Checklist for DSM 5), is associated with change in biological age
Measured: Assessment will compare the difference in PHQ-9/PCL-5 scores from baseline to after treatment with change in biological age from baseline to post-treartment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, single arm
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TruDiagnostic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wild Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294835
- Sponsor's protocol ID
- TD-WH-001
- Status last verified
- Sep 2022
- First submitted
- 14 Mar 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Han LKM, Aghajani M, Clark SL, Chan RF, Hattab MW, Shabalin AA, Zhao M, Kumar G, Xie LY, Jansen R, Milaneschi Y, Dean B, Aberg KA, van den Oord EJCG, Penninx BWJH. Epigenetic Aging in Major Depressive Disorder. Am J Psychiatry. 2018 Aug 1;175(8):774-782. doi: 10.1176/appi.ajp.2018.17060595. Epub 2018 Apr 16.
PubMed 29656664Marcantoni WS, Akoumba BS, Wassef M, Mayrand J, Lai H, Richard-Devantoy S, Beauchamp S. A systematic review and meta-analysis of the efficacy of intravenous ketamine infusion for treatment resistant depression: January 2009 - January 2019. J Affect Disord. 2020 Dec 1;277:831-841. doi: 10.1016/j.jad.2020.09.007. Epub 2020 Sep 7.
PubMed 33065824Dawson KL, Carangan AMJM, Klunder J, Carreras-Gallo N, Sehgal R, Megilligan S, Askins BC, Perkins N, Mendez TL, Smith RM, Dawson MS, Mallin MP, Higgins-Chen AT, Dwaraka VB. Epigenetic aging and DNA methylation biomarker changes following ketamine treatment in patients with MDD and PTSD: a pilot study. Transl Psychiatry. 2025 Oct 31;15(1):452. doi: 10.1038/s41398-025-03683-y.
PubMed 41173838
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ketamine on Epigenetic Age (IKEA)
- ClinicalTrials.gov ID
- NCT05294835
- Acronym / sponsor ID
- TD-WH-001
- Conditions
- Depression, Post Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TruDiagnosticIndustry (pharma, biotech, devices)
- Collaborators
- Wild Health
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Mar 2022 (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 is a prospective, clinical pilot study (n=20) to evaluate the impact of a ketamine treatment for Major Depressive Disorder (MDD) or Post Traumatic Stress Disorder (PTSD) on epigenetic aging by the TruAge epigenetic age laboratory test.
Detailed description
Subjects with MDD or PTSD will have a series of six ketamine infusions over two to three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single arm
| Arm | Type | Receives |
|---|---|---|
| Ketamine Infusion | Experimental | Drug: Ketaminesubanesthetic ketamine infusion (0.5mg/kg) over 2-3 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Be 18-64 years old of any sex, gender orientation, and ethnicity
- Read, understand, and provide written informed consent in English,
- Meet criteria for a primary psychiatric diagnosis of Major Depressive Disorder (MDD) or Post-traumatic Stress Disorder (PTSD) for greater than 4 weeks,
- Have a history of at least 1 failed medication trial targeting MDD or PTSD
- Have a reliable form of transportation to lodging or home following the completion of each ketamine infusion treatment day,
Key exclusion criteria (11 listed)
- Delirium or dementia diagnosis,
- Unstable medical illness or clinically significant laboratory results,
- History of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at high risk for possible cardiac side effects, or uncontrolled hypertension
- History of multiple adverse drug reactions,
- Current or past history of psychotic disorder or psychotic symptoms,
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 |
|---|---|---|
| Ketamineketamine infusion | Drug | Ketamine Infusion |
Primary outcome
Epigenetic Age
Time frame: Biological age will be compared from baseline to study completion, an average of five weeks
DNA Methylation-derived epigenetic age
3 secondary outcomes
Severity of Illness and baseline epigenetic age
Time frame: Assessment will evaluate the correlation of data collected at baseline with data from after treatment is completed, on average five weeks
Severity of Illness and post-treatment epigenetic age
Time frame: Assessment will evaluate the correlation of data collected at baseline with biological age assessed after treatment is complete, on average five weeks
Degree of Treatment Response
Time frame: Assessment will compare the difference in PHQ-9/PCL-5 scores from baseline to after treatment with change in biological age from baseline to post-treartment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Background: PubMed 29656664Han LKM, Aghajani M, Clark SL, Chan RF, Hattab MW, Shabalin AA, Zhao M, Kumar G, Xie LY, Jansen R, Milaneschi Y, Dean B, Aberg KA, van den Oord EJCG, Penninx BWJH. Epigenetic Aging in Major Depressive Disorder. Am J Psychiatry. 2018 Aug 1;175(8):774-782. doi: 10.1176/appi.ajp.2018.17060595. Epub 2018 Apr 16.
- Background: PubMed 33065824Marcantoni WS, Akoumba BS, Wassef M, Mayrand J, Lai H, Richard-Devantoy S, Beauchamp S. A systematic review and meta-analysis of the efficacy of intravenous ketamine infusion for treatment resistant depression: January 2009 - January 2019. J Affect Disord. 2020 Dec 1;277:831-841. doi: 10.1016/j.jad.2020.09.007. Epub 2020 Sep 7.
- Derived from this study: PubMed 41173838Dawson KL, Carangan AMJM, Klunder J, Carreras-Gallo N, Sehgal R, Megilligan S, Askins BC, Perkins N, Mendez TL, Smith RM, Dawson MS, Mallin MP, Higgins-Chen AT, Dwaraka VB. Epigenetic aging and DNA methylation biomarker changes following ketamine treatment in patients with MDD and PTSD: a pilot study. Transl Psychiatry. 2025 Oct 31;15(1):452. doi: 10.1038/s41398-025-03683-y.
- "GrimAge," an epigenetic predictor of mortality, is accelerated in major depressive disorderLink provided by the sponsor.
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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.
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 Ketamine in people with Depression and Post Traumatic Stress Disorder, run by TruDiagnostic 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Klunder ((615) 278-6394, jessica.klunder@wildhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic Age (time frame: Biological age will be compared from baseline to study completion, an average of five 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 NCT05294835, which also lists 3 linked publications.
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 8 Sep 2022.