Ketamine and Epigenetic Aging

September 7, 2022 updated by: TruDiagnostic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Wild Health
        • Contact:
        • Principal Investigator:
          • Mike Mallin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epigenetic Age
Time Frame: Biological age will be compared from baseline to study completion, an average of five weeks
DNA Methylation-derived epigenetic age
Biological age will be compared from baseline to study completion, an average of five weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assess if severity of illness prior to treatment is associated with biological age before treatment
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
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
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.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TruDiagnostic

Collaborators

Wild Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD-WH-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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