Mitochondrial Function After Ketamine

NCT07399756 | Not Yet Recruiting

• 1 other identifier: SHEBA-05-2419-RA-CTIL
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Can changes in mitochondrial function serve as biomarkers for predicting or monitoring clinical response to S-ketamine treatment?

Conditions

Major Depressive Disorder

Keywords

ketamine, Mitochondrial, Treatment-Resistant Depression

Outcome Measures

Primary Outcomes (1)

• S-ketamine effects on the mitochondrial

  Does S-ketamine treatment modulate mitochondrial function in peripheral blood cells, as reflected by mitochondrial content and circulating mitochondrial biomarkers such as GDF15?

  3 hours and 6 weeks

Other Outcomes (1)

• mitochondrial function as a biomarker for S-ketamine treatment

  3 hours and 6 weeks

Study Arms (1)

Ketamine inhalation group

Treatment-Resistant Depression patient after Ketamine inhalation

Drug: S (+) Ketamine

Interventions

S (+) Ketamine DRUG

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

Ketamine inhalation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit ten normal controls, 30 Patients with the diagnosis of treatment-resistant depression (TRD), failed to at least two antidepressants

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel, 52621, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Mitochondrial DNA (mtDNA) copy number will be assessed using quantitative real-time PCR (RT-qPCR) from DNA isolated from PBMCs

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

revital amiaz, dr

CONTACT

972 035302538; revital.amiaz@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

IL (1)