Ketamine and Epigenetic Aging

TruDiagnostic

Status and phase

Enrolling

Phase 2

Conditions

Post Traumatic Stress Disorder

Depression

Treatments

Drug: Ketamine

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05294835

TD-WH-001

Details and patient eligibility

About

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.

Full description

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts 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