Recruiting
Phase 2

Ketamine & Epigenetic

Sponsor:

TruDiagnostic

Code:

NCT05294835

Conditions

Depression

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Ketamine

Study Details

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

Study ID

NCT05294835

Start date

Apr 1, 2022

Status verified date

Sep, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine Infusion

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

Interventions

Ketamine

ketamine infusion

Primary outcome measure

  • Epigenetic Age [ Time Frame: Biological age will be compared from baseline to study completion, an average of five weeks ]

Central Contacts and Locations

Central contacts

Jessica Klunder

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

Locations

Wild Health

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Jessica Klunder

615-278-6394jessica.klunder@wildhealth.com

Principal Investigator:

Mike Mallin, MD

More Information

Sponsor

TruDiagnostic

Last update posted

Sep 8, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TruDiagnostic on 2022-09-08.