Post Stroke DepressionNCT07423273
Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression
A study testing hyperbaric oxygen therapy in people with Post Stroke Depression, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The study evaluates the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Post Stroke Depression
- What is being tested?
- hyperbaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Nov 2023to 1 Dec 2030
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 -85
- Suffered an ischemic stroke 6 months to 7 years prior to their inclusion
- Treated or being treated by antidepressants for at least 3 months
- Diagnosis of PSD based on HDRS-17 score of 17 and above.
- Stable psychological and pharmacological treatment for more than three months prior to inclusion.
- Subject willing and able to read, understand and sign an informed consent.
Who cannot join
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease.
- Diagnosis of aphasia or major cognitive decline
- History of Deep brain stimulation (DBS)
- History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy
- Active malignancy
Show all 18Show fewer
- Substance use at baseline.
- History of other neurodegenerative diseases including Alzheimer's disease (AD), Parkinson's disease (PD), Lewy body dementia (LBD), Frontotemporal dementia (FTD), Multiple sclerosis (MS), Amyotrophic lateral sclerosis (ALS), Creutzfeld Jacob disease (CJD), Multisystem atrophy (MSA), Pseudobulbar palsy (PSP), Corticobasal degeneration (CBD), Wernicke Korsakoff syndrome
- Serious suicidal ideation
- Renal or liver insufficiency, electrolyte imbalances
- Chronic heart failure with ejection fraction of 30 or less
- HBOT for any reason prior to study enrolment
- Chest pathology incompatible with pressure changes (including active asthma or COPD)
- Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
- An inability to perform an awake brain MRI
- No evidence of vascular related lesions in the brain MRI
- Active smoking
- Participation in another study
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, 1 recruiting
- Recruiting
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Zrifin, 70300
Shai Efrati, Prof, 972-8-9779393, efratishai@outlook.com
About this study
Official title: Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression: A Prospective, Randomized, Double Blind Study
The study evaluates the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.
Read the detailed description
Post-stroke depression (PSD) is a prevalent mental health complication, affecting approximately 33% of stroke survivors. Its occurrence not only hinders rehabilitation and recovery from motor and cognitive deficits post-stroke but also escalates the risk of subsequent neurovascular events. Both biological and psychological factors are instrumental in the onset of PSD.
Ischemia plays a pivotal role in the development of long-term PSD due to its impact on specific brain regions, neurotransmitter systems, neural connectivity, inflammatory responses, and mitochondrial dysfunction.
brain ischemia can instigate a protracted cycle of inflammation, levels and functions of neurotransmitters, impaired mitochondrial function, that directly impinges on the brain's ability to undergo neuroplastic changes. This relationship underscores the importance of targeting the cure of brain ischemia in therapeutic strategies for PSD. Managing the brain ischemia could potentially salvage neuroplasticity and mitigate the mental and cognitive decline associated with PSD.
The new protocols of hyperbaric oxygen therapy (HBOT), using the hyperoxic-hypoxic paradox (HHP), is one of the first therapeutic intervention already in clinical use today for the specific goal of inducing regeneration of damaged brain tissue.
Cumulative data from recent years provide convincing evidence that HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in post-stroke patients.
Both neurological and cognitive functions were improved even years after the stroke.
The observed restoration of neuronal activity in the metabolically dysfunctional stunned areas indicates that HBOT is a potent means of delivering sufficient oxygen needed for activation of neuroplasticty and restoration of impaired functions.
HBOT was found to be effective in small clinical trials for patients suffering from post-stroke depression. In a meta-analysis done by Liang et al. the efficacy and safety of HBOT for PSD was evaluated. A total of 27 RCTs involving 2250 participants were identified. Patients in HBOT group had a higher response rate than patients in control group (response rate: 69.4% vs 51.2%, odds ratio [OR] = 2.51, 95% confidence interval [CI] [1.83-3.43], P = 0.000). HBOT significantly reduced Hamilton Depression (HAMD).
The aim of the current study is to evaluate the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.
- Conditions
- Post Stroke Depression
- Being tested
- hyperbaric oxygen therapy
- Keywords
- hyperbaric oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen therapyDevice
The HBOT protocol consists of 60 daily sessions, five times per week, each session lasting 90 minutes.
Investigational product:
Multiplace hyperbaric oxygen chamber (Haux, Germany) located at the Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Israel.
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric oxygen therapy (HBOT) active treatment | Active comparator | The HBOT protocol consists of 60 daily sessions, five times per week, within a three months' period. Then there will be a follow-up period for 3 months without any investigated intervention. each session lasting 90 minutes, of 100% oxygen at 2 ATA and 5-minute air breaks every 20 minutes. Receives: Device: hyperbaric oxygen therapy |
| Sham hyperbaric oxygen therapy (HBOT) Sham treatment | Sham comparator | All the conditions provided in the HBOT intervention will be provided in the sham intervention. However, in contrast to the HBOT, each session includes breathing 21% oxygen by mask while in the same multiplace chamber. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 90 minutes with 5-minute air breaks, every 20 minutes The initial 1.2 ATA level will provide a minimal pressure sensation in the ears, with the same nurse advice on pumping the ears. In the last five minutes of the session, the air will be circulated again with its related noises. Sham and HBOT sessions will never be adjacent, so subjects from the two groups cannot meet and discuss the session and its effects. Receives: Device: hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSD symptoms
Depression severity will be evaluated by structured interview based on the HDRS-17 guided structural questioner (Hamilton Depression Rating Scale from 0-53 ,Levels of depression is categorized according to the following accepted criteria:
- Not depressed: 0-7
- Mild (subthreshold): 8-13
- Moderate: 14-18
- Severe: 19-22
- Very severe: >23)
Measured: Change from Baseline immediately after the intervention
Secondary outcomes (24)
depression
Beck depression inventory II. Each answer is scored on a scale value of 0 to 3 . The score ranges between 0 and 63, with higher scores indicating more severe depression symptoms.
Measured: Change from Baseline immediately after the intervention
Short form health survey (sf-36)
Quality of life questionnaire, scale of 0-100, higher score means better outcome
Measured: at baseline, 3 months, 6 months
psychological distress
The Brief Symptom Inventory-18 (BSI-18). self-report questionnaire which generates a summary scale, the global stress index (GSI), and three subscales: depression, anxiety, and somatization. Each item is rated on a 5-point scale, with distress ratings ranging from 0 (not at all) to 4 (extremely) .
Measured: Change from Baseline immediately after the intervention
health status
Changes will be measured by The Stroke Impact Scale (SIS). The SIS version 3.0 includes 59 items, An extra question on stroke recovery asks that the client rate on a scale from 0 - 100 how much the client feels that he/she has recovered from his/her stroke.
Measured: Change from Baseline immediately after the intervention
independent living skills
Changes will be measured by Instrumental Activities of Daily Living (IADL) Scale. There are eight domains of function measured with the Lawton IADL scale. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Measured: Change from Baseline immediately after the intervention
NeuroTrax
computerized cognitive evaluation battery. each outcome parameter will be normalized and fit to an IQ-like scale (mean=100, STD=15), according to the participants' age and education.
Measured: at baseline, 3 months
MoCA
Montreal Cognitive Assessment (MoCA). The maximum MoCA score is 30 points, with a 1-point scoring correction for individuals with 12 years of education or less. A score of 26 or above is considered normal and a score lower than 26 has been considered to be the optimal cutoff point for diagnosis of cognitive impairment.
Measured: Change from Baseline immediately after the intervention
CANTAB Cambridge Neuropsychological Test Automated Battery
computerized cognitive evaluation battery test, divided into 2 tasks: 1- Multitasking test (MTT)- attention, reaction time and executive functions, Multitasking test Incongruency cost - A higher incongruency cost indicates that the subjects takes longer to process conflicting information. 2-Paired associated learning (PAL)- visual memory and new learning, PAL Number of Patterns Reached (0-8), PAL Total Errors (Adjusted) (0-64), PAL Total Attempts(0-64).
Measured: at baseline, 3 months
MRI Imaging
At each of the evaluations, patients will undergo structural and functional MRI scanning. Images will be acquired on Vida 3 Tesla Scanner, configured with a 64-channel receiver head coils (Siemens Healthcare, Erlangen, Germany) at Shamir medical center radiology department.
Measured: Change from Baseline immediately after the intervention
fMRI Imaging
Resting state fMRI(rsfMRI or R-fMRI)- a method of functional brain imaging that can be used to evaluate regional interactions that occur when a subject is not performing an explicit task. This resting brain activity is observed through changes in blood flow in the brain which creates what is referred to as a blood-oxygen-level dependent (BOLD) signal that can be measured using functional Magnetic Resonance Imaging (fMRI).
Measured: Change from Baseline immediately after the intervention
Physical, Neurological and functional evaluation
A general physical and neurological evaluation will be done. NIHSS - The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS), will be used as part of the neurological evaluation to objectively quantify the impairment caused by the stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4 .For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
Measured: Change from Baseline immediately after the intervention
electrical brain activity
Quantitative EEG (qEEG) including task related EEG analysis. EEG analysis for each state within subject and between subjects will include frequency analysis (peak frequency and relative power), oscillations (proportions of the different bands alpha, beta, theta, delta activities) and power spectra distribution.
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 1
blood tests will include Inflammatory markers: IL-1 (IL-1β): pg/mL
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 2
blood tests will include Inflammatory markers: IL-6: pg/mL
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 3
blood tests will include Inflammatory markers: Tumor necrosis factor-alpha (TNF-α): pg/mL
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 4
blood tests will include Inflammatory markers: hsCRP (high-sensitivity C-reactive protein): mg/L
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 5
blood tests will include Inflammatory markers: Exosomes: particles/mL (by NTA) or µg protein/mL (by protein assay)
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 6
blood tests will include Inflammatory markers: Serum VEGF: pg/mL
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 7
blood tests will include Inflammatory markers: Testosterone (serum): ng/dL or nmol/L
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 8
blood tests will include Inflammatory markers: Estradiol (E2, serum): pg/mL or pmol/L
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 9
blood tests will include Inflammatory markers: DHEA-S (serum): µg/dL (commonly) or µmol/L
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 10
blood tests will include Inflammatory markers: Progesterone (serum): ng/mL or nmol/L
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 11
blood tests will include Inflammatory markers: Cortisol (serum): µg/dL or nmol/L
Measured: Change from Baseline immediately after the intervention
Inflammatory cytokines 12
blood tests will include Inflammatory markers: Telomere length: kilobases (kb) or relative T/S ratio (qPCR, arbitrary units)
Measured: Change from Baseline immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start8 Nov 2023
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke DepressionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- hyperbaric oxygen therapy (2ATA, 100% oxygen) vs. sham (1.2ATA, 21% oxygen)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Efrati, Assaf-Harofeh Medical Center
- Investigators
- Shai a Efrati, MD, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423273
- Sponsor's protocol ID
- 0202-23
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression: A Prospective, Randomized, Double Blind Study
- ClinicalTrials.gov ID
- NCT07423273
- Acronym / sponsor ID
- 0202-23
- Conditions
- Post Stroke Depression
- Keywords
- hyperbaric oxygen therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 20 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 study evaluates the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.
Detailed description
Post-stroke depression (PSD) is a prevalent mental health complication, affecting approximately 33% of stroke survivors. Its occurrence not only hinders rehabilitation and recovery from motor and cognitive deficits post-stroke but also escalates the risk of subsequent neurovascular events. Both biological and psychological factors are instrumental in the onset of PSD.
Ischemia plays a pivotal role in the development of long-term PSD due to its impact on specific brain regions, neurotransmitter systems, neural connectivity, inflammatory responses, and mitochondrial dysfunction.
brain ischemia can instigate a protracted cycle of inflammation, levels and functions of neurotransmitters, impaired mitochondrial function, that directly impinges on the brain's ability to undergo neuroplastic changes. This relationship underscores the importance of targeting the cure of brain ischemia in therapeutic strategies for PSD. Managing the brain ischemia could potentially salvage neuroplasticity and mitigate the mental and cognitive decline associated with PSD.
The new protocols of hyperbaric oxygen therapy (HBOT), using the hyperoxic-hypoxic paradox (HHP), is one of the first therapeutic intervention already in clinical use today for the specific goal of inducing regeneration of damaged brain tissue.
Cumulative data from recent years provide convincing evidence that HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in post-stroke patients.
Both neurological and cognitive functions were improved even years after the stroke.
The observed restoration of neuronal activity in the metabolically dysfunctional stunned areas indicates that HBOT is a potent means of delivering sufficient oxygen needed for activation of neuroplasticty and restoration of impaired functions.
HBOT was found to be effective in small clinical trials for patients suffering from post-stroke depression. In a meta-analysis done by Liang et al. the efficacy and safety of HBOT for PSD was evaluated. A total of 27 RCTs involving 2250 participants were identified. Patients in HBOT group had a higher response rate than patients in control group (response rate: 69.4% vs 51.2%, odds ratio [OR] = 2.51, 95% confidence interval [CI] [1.83-3.43], P = 0.000). HBOT significantly reduced Hamilton Depression (HAMD).
The aim of the current study is to evaluate the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- hyperbaric oxygen therapy (2ATA, 100% oxygen) vs. sham (1.2ATA, 21% oxygen)
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen therapy (HBOT) active treatment | Active comparator | Device: hyperbaric oxygen therapyThe HBOT protocol consists of 60 daily sessions, five times per week, within a three months' period. Then there will be a follow-up period for 3 months without any investigated intervention. each session lasting 90 minutes, of 100% oxygen at 2 ATA and 5-minute air breaks every 20 minutes. |
| Sham hyperbaric oxygen therapy (HBOT) Sham treatment | Sham comparator | Device: hyperbaric oxygen therapyAll the conditions provided in the HBOT intervention will be provided in the sham intervention. However, in contrast to the HBOT, each session includes breathing 21% oxygen by mask while in the same multiplace chamber. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 90 minutes with 5-minute air breaks, every 20 minutes The initial 1.2 ATA level will provide a minimal pressure sensation in the ears, with the same nurse advice on pumping the ears. In the last five minutes of the session, the air will be circulated again with its related noises. Sham and HBOT sessions will never be adjacent, so subjects from the two groups cannot meet and discuss the session and its effects. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 50 -85
- Suffered an ischemic stroke 6 months to 7 years prior to their inclusion
- Treated or being treated by antidepressants for at least 3 months
- Diagnosis of PSD based on HDRS-17 score of 17 and above.
- Stable psychological and pharmacological treatment for more than three months prior to inclusion.
Key exclusion criteria (18 listed)
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease.
- Diagnosis of aphasia or major cognitive decline
- History of Deep brain stimulation (DBS)
- History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy
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 |
|---|---|---|
| hyperbaric oxygen therapyThe HBOT protocol consists of 60 daily sessions, five times per week, each session lasting 90 minutes. Investigational product: Multiplace hyperbaric oxygen chamber (Haux, Germany) located at the Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Israel. | Device | Sham hyperbaric oxygen therapy (HBOT) Sham treatment, hyperbaric oxygen therapy (HBOT) active treatment |
Primary outcome
PSD symptoms
Time frame: Change from Baseline immediately after the intervention
Depression severity will be evaluated by structured interview based on the HDRS-17 guided structural questioner (Hamilton Depression Rating Scale from 0-53 ,Levels of depression is categorized according to the following accepted criteria: * Not depressed: 0-7 * Mild (subthreshold): 8-13 * Moderate: 14-18 * Severe: 19-22 * Very severe: >23)
24 secondary outcomes
depression
Time frame: Change from Baseline immediately after the intervention
Short form health survey (sf-36)
Time frame: at baseline, 3 months, 6 months
psychological distress
Time frame: Change from Baseline immediately after the intervention
health status
Time frame: Change from Baseline immediately after the intervention
independent living skills
Time frame: Change from Baseline immediately after the intervention
NeuroTrax
Time frame: at baseline, 3 months
MoCA
Time frame: Change from Baseline immediately after the intervention
CANTAB Cambridge Neuropsychological Test Automated Battery
Time frame: at baseline, 3 months
MRI Imaging
Time frame: Change from Baseline immediately after the intervention
fMRI Imaging
Time frame: Change from Baseline immediately after the intervention
Physical, Neurological and functional evaluation
Time frame: Change from Baseline immediately after the intervention
electrical brain activity
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 1
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 2
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 3
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 4
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 5
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 6
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 7
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 8
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 9
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 10
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 11
Time frame: Change from Baseline immediately after the intervention
Inflammatory cytokines 12
Time frame: Change from Baseline immediately after the intervention
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 17 Apr 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.
Shai a Efrati, MD principal investigator
Asaf-Harofhe MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen therapy in people with Post Stroke Depression, run by Assaf-Harofeh 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 6 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 17 Apr 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. Some participants in this study may receive a placebo. 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 Shai a Efrati, MD (972549212866, efratishai@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSD symptoms (time frame: Change from Baseline immediately after the intervention). 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 17 Apr 2026.