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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05294835
Other study ID # TD-WH-001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 1, 2022
Est. completion date December 31, 2022

Study information

Verified date September 2022
Source TruDiagnostic
Contact Jessica Klunder
Phone (615) 278-6394
Email jessica.klunder@wildhealth.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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


Intervention

Drug:
Ketamine
ketamine infusion

Locations

Country Name City State
United States Wild Health Lexington Kentucky

Sponsors (2)

Lead Sponsor Collaborator
TruDiagnostic Wild Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Epigenetic Age DNA Methylation-derived epigenetic age Biological age will be compared from baseline to study completion, an average of five weeks
Secondary Severity of Illness and baseline epigenetic age Assess if severity of illness prior to treatment is associated with biological age before treatment Assessment will evaluate the correlation of data collected at baseline with data from after treatment is completed, on average five weeks
Secondary Severity of Illness and post-treatment epigenetic age Assess if severity of illness, as measured by PHQ-9 (Patient Health Questionnaire-9) or PCL-5 (PTSD Checklist for DSM 5) prior to treatment is associated with biological age after treatment Assessment will evaluate the correlation of data collected at baseline with biological age assessed after treatment is complete, on average five weeks
Secondary Degree of Treatment Response Assess if degree of treatment response to ketamine infusion, as measured by PHQ-9 (Patient Health Questionnaire-9) or PCL-5 (PTSD Checklist for DSM 5), is associated with change in biological age 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.
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