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Unknown statusPhase 2

Ketamine and Epigenetic Aging

NCT05294835 · TruDiagnostic

Closed to entry
Status
Not accepting participants
Phase 2
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Epigenetic Age

    Measured over Biological age will be compared from baseline to study completion, an average of five weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * 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, * 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. Exclusion Criteria: * 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, * 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

Where

1 study site

FacilityCityRegionCountry
Wild HealthLexingtonKentuckyUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05294835 on ClinicalTrials.gov →

Last updated in the registry 2022-09-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits