Ketamine and Epigenetic Aging

Depression Clinical Trial

Official title:

Impact of Ketamine on Epigenetic Age (IKEA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294835
• Other study ID #: TD-WH-001
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: TruDiagnostic
• Contact: Jessica Klunder
• Phone: (615) 278-6394
• Email: jessica.klunder[@]wildhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Ketamine
ketamine infusion

Locations

Country	Name	City	State
United States	Wild Health	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
TruDiagnostic	Wild Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epigenetic Age	DNA Methylation-derived epigenetic age	Biological age will be compared from baseline to study completion, an average of five weeks
Secondary	Severity of Illness and baseline epigenetic age	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
Secondary	Severity of Illness and post-treatment epigenetic age	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
Secondary	Degree of Treatment Response	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.

External Links

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