Mitochondrial Function After Ketamine

NCT07399756 · tracked via the Priya Life Science Israel tracker

Sponsor

Sheba Medical Center

Phase

Observational

Started

2026-02

Last updated

2026-02-10

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

S (+) Ketamine →

S (+) Ketamine: the patients are treated with S-Ketamine in order to treat there Treatment-Resistant Depression via inhalation

Study summary

The goal of this observational study is to learn about the role of mitochondria in response to S-ketamine. in individuals with Treatment-Resistant Depression.

the Research Questions are

1. Does S-ketamine treatment modulate mitochondrial function in peripheral blood cells, as reflected by mitochondrial content and circulating mitochondrial biomarkers such as GDF15?
2. Can changes in mitochondrial function serve as biomarkers for predicting or monitoring clinical response to S-ketamine treatment?

Samples will be collected at baseline, 3 hours after the first treatment, and 6 weeks post-exposure, and compared between responders and non-responders

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: Male or female, 18-65 years of age Diagnosis of Major Depressive Disorder according to the DSM-V Patient has a HAM-D≥23 Treatment resistant -Did not respond to two antidepressants trial Medically stable: No active physical disease: malignancy, cardiac condition, hypertension , stable medications for the past month etc. Exclusion Criteria: Known sensitivity to ketamine drug or alcohol abuse Patient taking lithium or corticosteroids Pregnant or breast-feeding has another axis I diagnosis attention deficits disorder a history or current serious neurological, metabolic autoimmune bone marrow, oncologic or additional psychiatric disorders

Primary outcome measure(s)

S-ketamine effects on the mitochondrial — 3 hours and 6 weeks
Does S-ketamine treatment modulate mitochondrial function in peripheral blood cells, as reflected by mitochondrial content and circulating mitochondrial biomarkers such as GDF15?

Trial sites (1)

Facility	City	Region	Status
Sheba Medical Center	Ramat Gan	Israel

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07399756 on ClinicalTrials.gov ↗ ← All trials in Israel