Ketamine and Epigenetic Aging

Sponsor

TruDiagnostic (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05294835

Collaborator

Wild Health (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Post Traumatic Stress Disorder	Drug: Ketamine	Phase 2

Detailed Description

Subjects with MDD or PTSD will have a series of six ketamine infusions over two to three weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

prospective, single armprospective, single arm

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of Ketamine on Epigenetic Age (IKEA)

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketamine Infusion subanesthetic ketamine infusion (0.5mg/kg) over 2-3 weeks	Drug: Ketamine ketamine infusion

Arm

Intervention/Treatment

Experimental: Ketamine Infusion

subanesthetic ketamine infusion (0.5mg/kg) over 2-3 weeks

Drug: Ketamine

ketamine infusion

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wild Health	Lexington	Kentucky	United States	40503

Sponsors and Collaborators

TruDiagnostic
Wild Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

"GrimAge," an epigenetic predictor of mortality, is accelerated in major depressive disorder

Publications

Responsible Party:

TruDiagnostic

ClinicalTrials.gov Identifier:

NCT05294835

Other Study ID Numbers:

TD-WH-001

First Posted:

Mar 24, 2022

Last Update Posted:

Apr 26, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Ketamine

Study Results

No Results Posted as of Apr 26, 2022