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New treatment option for Post Stroke Depression
Official title Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression
ClinicalTrials.gov ID: NCT07423273
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zrifin, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zrifin, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.