Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07399756

Mitochondrial Function After Ketamine

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S (+) Ketamine

Drug

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

Primary outcomes

  1. S-ketamine effects on the mitochondrial

    Time frame: 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?

Other outcomes

  1. mitochondrial function as a biomarker for S-ketamine treatment

    Time frame: 3 hours and 6 weeks

    Can changes in mitochondrial function serve as biomarkers for predicting or monitoring clinical response to S-ketamine treatment

Study contacts

Contact information is provided by the study sponsor or research team.

revital amiaz, dr

CONTACT

[email protected]

972 035302538

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

Assessment of Mitochondrial Parameters in Blood Before and After S-Ketamine Treatment

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.