Ketamine and Epigenetic Aging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Depression Post Traumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, single arm

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ketamine Infusion

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

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

ketamine infusion

Interventions

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Ketamine

ketamine infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes