NCT05294835RecruitingPhase 2
Impact of Ketamine on Epigenetic Age (IKEA)
TruDiagnostic1 site in 1 country20 target enrollmentStarted: April 1, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Epigenetic Age
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Ketamine Infusion
Experimental
subanesthetic ketamine infusion (0.5mg/kg) over 2-3 weeks
Intervention: Ketamine (Drug)
Outcomes
Primary Outcomes
Epigenetic Age
Time Frame: Biological age will be compared from baseline to study completion, an average of five weeks
DNA Methylation-derived epigenetic age
Secondary Outcomes
- Degree of Treatment Response(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.)
- Severity of Illness and baseline epigenetic age(Assessment will evaluate the correlation of data collected at baseline with data from after treatment is completed, on average five weeks)
- Severity of Illness and post-treatment epigenetic age(Assessment will evaluate the correlation of data collected at baseline with biological age assessed after treatment is complete, on average five weeks)
Investigators
Study Sites (1)
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