Clinical trial NCT05294835: Ketamine and Epigenetic Aging
Official title: Impact of Ketamine on Epigenetic Age (IKEA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depression
Post Traumatic Stress Disorder
Lead sponsor: TruDiagnostic
Sponsor class: INDUSTRY
Collaborators: name: Wild Health
First posted: 2022-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, single arm
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Epigenetic Age
timeFrame: Biological age will be compared from baseline to study completion, an average of five weeks
Secondary outcomes:
measure: Severity of Illness and baseline epigenetic age
timeFrame: Assessment will evaluate the correlation of data collected at baseline with data from after treatment is completed, on average five weeks
measure: Severity of Illness and post-treatment epigenetic age
timeFrame: Assessment will evaluate the correlation of data collected at baseline with biological age assessed after treatment is complete, on average five weeks
measure: Degree of Treatment Response
timeFrame: 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.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Wild Health
state: Kentucky
Study officials:
References:
citation: Han LKM, Aghajani M, Clark SL, Chan RF, Hattab MW, Shabalin AA, Zhao M, Kumar G, Xie LY, Jansen R, Milaneschi Y, Dean B, Aberg KA, van den Oord EJCG, Penninx BWJH. Epigenetic Aging in Major Depressive Disorder. Am J Psychiatry. 2018 Aug 1;175(8):774-782. doi: 10.1176/appi.ajp.2018.17060595. Epub 2018 Apr 16.
citation: Marcantoni WS, Akoumba BS, Wassef M, Mayrand J, Lai H, Richard-Devantoy S, Beauchamp S. A systematic review and meta-analysis of the efficacy of intravenous ketamine infusion for treatment resistant depression: January 2009 - January 2019. J Affect Disord. 2020 Dec 1;277:831-841. doi: 10.1016/j.jad.2020.09.007. Epub 2020 Sep 7.