Major Depressive DisorderNCT07399756
Mitochondrial Function After Ketamine
An observational study of Major Depressive Disorder, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- S (+) Ketamine
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2026to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit ten normal controls, 30 Patients with the diagnosis of treatment-resistant depression (TRD), failed to at least two antidepressants
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Sheba Medical Center
Ramat Gan, Israel, 52621
tzur mayer, dr, 972 035303318, tzur.mayer@sheba.health.gov.il
revital amiaz, dr, 972035302538, revital.amiaz@sheba.health.gov.il
About this study
Official title: Assessment of Mitochondrial Parameters in Blood Before and After S-Ketamine Treatment
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
- Does S-ketamine treatment modulate mitochondrial function in peripheral blood cells, as reflected by mitochondrial content and circulating mitochondrial biomarkers such as GDF15?
- 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
- Conditions
- Major Depressive Disorder
- Being tested
- S (+) Ketamine
- Keywords
- ketamine, Mitochondrial, Treatment-Resistant Depression
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S (+) KetamineDrug
the patients are treated with S-Ketamine in order to treat there Treatment-Resistant Depression via inhalation
| Study group | Role | What they receive |
|---|---|---|
| Ketamine inhalation group | Treatment-Resistant Depression patient after Ketamine inhalation Receives: Drug: S (+) Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 3 hours and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399756
- Sponsor's protocol ID
- SHEBA-05-2419-RA-CTIL
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mitochondrial Parameters in Blood Before and After S-Ketamine Treatment
- ClinicalTrials.gov ID
- NCT07399756
- Acronym / sponsor ID
- SHEBA-05-2419-RA-CTIL
- Conditions
- Major Depressive Disorder
- Keywords
- ketamine, Mitochondrial, Treatment-Resistant Depression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Feb 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Does S-ketamine treatment modulate mitochondrial function in peripheral blood cells, as reflected by mitochondrial content and circulating mitochondrial biomarkers such as GDF15?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine inhalation group | – | Drug: S (+) KetamineTreatment-Resistant Depression patient after Ketamine inhalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit ten normal controls, 30 Patients with the diagnosis of treatment-resistant depression (TRD), failed to at least two antidepressants
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S (+) Ketaminethe patients are treated with S-Ketamine in order to treat there Treatment-Resistant Depression via inhalation | Drug | Ketamine inhalation group |
Primary outcome
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?
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact revital amiaz, dr (972 035302538, revital.amiaz@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S-ketamine effects on the mitochondrial (time frame: 3 hours and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.