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Ketamine and Epigenetic Aging

Primary Purpose

Depression, Post Traumatic Stress Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Sponsored by
TruDiagnostic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wild HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketamine Infusion

Arm Description

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

Outcomes

Primary Outcome Measures

Epigenetic Age
DNA Methylation-derived epigenetic age

Secondary Outcome Measures

Severity of Illness and baseline epigenetic age
Assess if severity of illness prior to treatment is associated with biological age before treatment
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
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

Full Information

First Posted
March 14, 2022
Last Updated
September 7, 2022
Sponsor
TruDiagnostic
Collaborators
Wild Health
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1. Study Identification

Unique Protocol Identification Number
NCT05294835
Brief Title
Ketamine and Epigenetic Aging
Official Title
Impact of Ketamine on Epigenetic Age (IKEA)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TruDiagnostic
Collaborators
Wild Health

4. Oversight

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
Data Monitoring Committee
No

5. 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.
Detailed Description
Subjects with MDD or PTSD will have a series of six ketamine infusions over two to three weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
prospective, single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine Infusion
Arm Type
Experimental
Arm Description
subanesthetic ketamine infusion (0.5mg/kg) over 2-3 weeks
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
ketamine infusion
Primary Outcome Measure Information:
Title
Epigenetic Age
Description
DNA Methylation-derived epigenetic age
Time Frame
Biological age will be compared from baseline to study completion, an average of five weeks
Secondary Outcome Measure Information:
Title
Severity of Illness and baseline epigenetic age
Description
Assess if severity of illness prior to treatment is associated with biological age before treatment
Time Frame
Assessment will evaluate the correlation of data collected at baseline with data from after treatment is completed, on average five weeks
Title
Severity of Illness and post-treatment epigenetic age
Description
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
Time Frame
Assessment will evaluate the correlation of data collected at baseline with biological age assessed after treatment is complete, on average five weeks
Title
Degree of Treatment Response
Description
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
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Klunder
Phone
(615) 278-6394
Email
jessica.klunder@wildhealth.com
Facility Information:
Facility Name
Wild Health
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Klunder
Phone
615-278-6394
Email
jessica.klunder@wildhealth.com
First Name & Middle Initial & Last Name & Degree
Mike Mallin, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29656664
Citation
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.
Results Reference
background
PubMed Identifier
33065824
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.
Results Reference
background
Links:
URL
https://www.nature.com/articles/s41398-021-01302-0
Description
"GrimAge," an epigenetic predictor of mortality, is accelerated in major depressive disorder

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Ketamine and Epigenetic Aging

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