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Can pressurized oxygen lift the fog of Post-Stroke depression?

NCT ID NCT07423273

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) can reduce depression in people who have had a stroke. Researchers will compare the treatment to a sham (fake) procedure in 142 adults aged 50-85 who have been depressed for at least 3 months despite medication. The goal is to see if this non-drug approach can improve mood and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hyperbaric oxygen therapy
What this could lead to
If it works, this could offer a new way to treat depression that lingers after a stroke, without adding more medication.
What could go wrong
This is a small, early-stage trial with no phase designation. The treatment requires 60 daily sessions, which may be hard to complete, and results may not apply to all stroke survivors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age between 50 -85 2. Suffered an ischemic stroke 6 months to 7 years prior to their inclusion 3. Treated or being treated by antidepressants for at least 3 months 4. Diagnosis of PSD based on HDRS-17 score of 17 and above. 5. Stable psychological and pharmacological treatment for more than three months prior to inclusion. 6. Subject willing and able to read, understand and sign an informed consent. Exclusion Criteria: 1. Inability to attend scheduled clinic visits and/or comply with the study protocol 2. Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease. 3. Diagnosis of aphasia or major cognitive decline 4. History of Deep brain stimulation (DBS) 5. History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy 6. Active malignancy 7. Substance use at baseline. 8. 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 9. Serious suicidal ideation 10. Renal or liver insufficiency, electrolyte imbalances 11. Chronic heart failure with ejection fraction of 30 or less 12. HBOT for any reason prior to study enrolment 13. Chest pathology incompatible with pressure changes (including active asthma or COPD) 14. Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year) 15. An inability to perform an awake brain MRI 16. No evidence of vascular related lesions in the brain MRI 17. Active smoking 18. Participation in another study

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

    RECRUITING

    Zrifin, 70300, Israel

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