Clinical TrialDepressive DisordersKetamineNot yet recruiting

Mitochondrial Function After Ketamine

This observational study will assess the impact of esketamine treatment on mitochondrial function in individuals with Treatment-Resistant Depression (n=30). The primary aim is to investigate how esketamine influences mitochondrial parameters in peripheral blood cells, including mitochondrial content and circulating biomarkers such as GDF15, and to determine if these changes can serve as predictors or monitors of clinical response to the treatment. Participants will be evaluated at baseline, 3 hours after the initial esketamine inhalation, and again 6 weeks post-treatment. Eligible individuals are aged 18 to 65, diagnosed with Major Depressive Disorder, and have not responded to at least two prior antidepressant trials. Exclusion criteria include known sensitivities to ketamine, certain medical conditions, and concurrent use of specific medications. The study is sponsored by Sheba Medical Center and is expected to commence in February 2026, with completion anticipated by January 2028.

Target Enrollment
30 participants
Study Type
interventional
Design
Non-randomized

Detailed Description

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

Study Arms & Interventions

Ketamine inhalation group

Treatment-Resistant Depression patient after Ketamine inhalation

Interventions

  • Ketamine
    via Other

Participants

Ages
18 – ?
Sexes
All

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

Study Details

  • Status
    Not yet recruiting
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment30 participants
  • Timeline
    Start: 2026-02-01
    End: 2028-01-01
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Study Team

Sponsors & Collaborators

Locations

Sheba Medical Center — Ramat Gan, Israel, Israel

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