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Ketamine and Epigenetic Aging

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ClinicalTrials.gov Identifier: NCT05294835
Recruitment Status : Recruiting
First Posted : March 24, 2022
Last Update Posted : April 26, 2022
Sponsor:
Collaborator:
Wild Health
Information provided by (Responsible Party):
TruDiagnostic

Tracking Information
First Submitted Date  ICMJE March 14, 2022
First Posted Date  ICMJE March 24, 2022
Last Update Posted Date April 26, 2022
Actual Study Start Date  ICMJE April 1, 2022
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2022)		 Epigenetic Age [ Time Frame: Biological age will be compared from baseline to study completion, an average of five weeks ]
DNA Methylation-derived epigenetic age
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2022)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine and Epigenetic Aging
Official Title  ICMJE Impact of Ketamine on Epigenetic Age (IKEA)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
prospective, single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Post Traumatic Stress Disorder
Intervention  ICMJE Drug: Ketamine
ketamine infusion
Study Arms  ICMJE Experimental: Ketamine Infusion
subanesthetic ketamine infusion (0.5mg/kg) over 2-3 weeks
Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2022)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jessica Klunder (615) 278-6394 jessica.klunder@wildhealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05294835
Other Study ID Numbers  ICMJE TD-WH-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party TruDiagnostic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE TruDiagnostic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Wild Health
Investigators  ICMJE Not Provided
PRS Account TruDiagnostic
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP