Ketamine and Epigenetic Aging

NCT05294835 | Unknown Phase 2 FDA Drug

• 1 other identifier: TD-WH-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Epigenetic Age

  DNA Methylation-derived epigenetic age

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

Secondary Outcomes (3)

• 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

• 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

• 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.

Study Arms (1)

Ketamine Infusion

EXPERIMENTAL

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

Drug: Ketamine

Interventions

Ketamine DRUG

ketamine infusion

Ketamine Infusion

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TruDiagnostic: lead
• Wild Health: collaborator

Study Sites (1)

Wild Health

Lexington, Kentucky, 40503, United States

RECRUITING

Related Publications (3)

• Han LKM, Aghajani M, Clark SL, Chan RF, Hattab MW, Shabalin AA, Zhao M, Kumar G, Xie LY, Jansen R, Milaneschi Y, Dean B, Aberg KA, van den Oord EJCG, Penninx BWJH. Epigenetic Aging in Major Depressive Disorder. Am J Psychiatry. 2018 Aug 1;175(8):774-782. doi: 10.1176/appi.ajp.2018.17060595. Epub 2018 Apr 16.

  PMID: 29656664 BACKGROUND

• Marcantoni WS, Akoumba BS, Wassef M, Mayrand J, Lai H, Richard-Devantoy S, Beauchamp S. A systematic review and meta-analysis of the efficacy of intravenous ketamine infusion for treatment resistant depression: January 2009 - January 2019. J Affect Disord. 2020 Dec 1;277:831-841. doi: 10.1016/j.jad.2020.09.007. Epub 2020 Sep 7.

  PMID: 33065824 BACKGROUND

• Dawson KL, Carangan AMJM, Klunder J, Carreras-Gallo N, Sehgal R, Megilligan S, Askins BC, Perkins N, Mendez TL, Smith RM, Dawson MS, Mallin MP, Higgins-Chen AT, Dwaraka VB. Epigenetic aging and DNA methylation biomarker changes following ketamine treatment in patients with MDD and PTSD: a pilot study. Transl Psychiatry. 2025 Oct 31;15(1):452. doi: 10.1038/s41398-025-03683-y.

  PMID: 41173838 DERIVED

Related Links

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

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Jessica Klunder

CONTACT

(615) 278-6394; jessica.klunder@wildhealth.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, single arm

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 24, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

US (1)