Ketamine and Epigenetic Aging
- Registration Number
- NCT05294835
- Lead Sponsor
- TruDiagnostic
- Brief 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.
- Detailed Description
Subjects with MDD or PTSD will have a series of six ketamine infusions over two to three weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ketamine Infusion Ketamine subanesthetic ketamine infusion (0.5mg/kg) over 2-3 weeks
- Primary Outcome Measures
Name Time Method Epigenetic Age Biological age will be compared from baseline to study completion, an average of five weeks DNA Methylation-derived epigenetic age
- Secondary Outcome Measures
Name Time Method Degree of Treatment Response 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. 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
Severity of Illness and baseline epigenetic age Assessment will evaluate the correlation of data collected at baseline with data from after treatment is completed, on average five weeks Assess if severity of illness prior to treatment is associated with biological age before treatment
Severity of Illness and post-treatment epigenetic age Assessment will evaluate the correlation of data collected at baseline with biological age assessed after treatment is complete, on average five weeks 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
Trial Locations
- Locations (1)
Wild Health
🇺🇸Lexington, Kentucky, United States