We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine and Epigenetic Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05294835
Recruitment Status : Recruiting
First Posted : March 24, 2022
Last Update Posted : September 8, 2022
Sponsor:
Collaborator:
Wild Health
Information provided by (Responsible Party):
TruDiagnostic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Ketamine on Epigenetic Age (IKEA)
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Epigenetic Age [ Time Frame: Biological age will be compared from baseline to study completion, an average of five weeks ]
    DNA Methylation-derived epigenetic age


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05294835


Contacts
Layout table for location contacts
Contact: Jessica Klunder (615) 278-6394 jessica.klunder@wildhealth.com

Locations
Layout table for location information
United States, Kentucky
Wild Health Recruiting
Lexington, Kentucky, United States, 40503
Contact: Jessica Klunder    615-278-6394    jessica.klunder@wildhealth.com   
Principal Investigator: Mike Mallin, MD         
Sponsors and Collaborators
TruDiagnostic
Wild Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: TruDiagnostic
ClinicalTrials.gov Identifier: NCT05294835    
Other Study ID Numbers: TD-WH-001
First Posted: March 24, 2022    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: September 2022

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action