NCT07423273Recruiting
Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression
Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression: A Prospective, Randomized, Double Blind Study
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 142 (estimated)
- First submitted
- 15 Apr 2024
- Start date
- 8 Nov 2023
- Primary completion date
- 1 Dec 2030
- Lead sponsor
- Assaf-Harofeh Medical Center
- Diseases
- Stroke
- NCT number
- NCT07423273
What you commit to
- Study type: Interventional
- Planned participants: 142
- From 8 Nov 2023 to the primary completion date, 1 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease.
- HBOT for any reason prior to study enrolment
Other illness
- History of Deep brain stimulation (DBS)
- History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy
- Active malignancy
- 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
- Renal or liver insufficiency, electrolyte imbalances
Lab values
- Chronic heart failure with ejection fraction of 30 or less
Other
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Diagnosis of aphasia or major cognitive decline
- Substance use at baseline.
- Serious suicidal ideation
- 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
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh) Coordinator of this site? Confirm its status | Zrifin | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.