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Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

ConditionPost Stroke Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorAssaf-Harofeh Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • hyperbaric oxygen therapy

    Device

    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.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: hyperbaric oxygen therapy (HBOT) active treatmentActive comparator 1 intervention
Group B: Sham hyperbaric oxygen therapy (HBOT) Sham treatmentSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Change from Baseline immediately after the intervention

Secondary outcomes

1

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.

Time frame
Change from Baseline immediately after the intervention
2

Short form health survey (sf-36)

Quality of life questionnaire, scale of 0-100, higher score means better outcome

Time frame
at baseline, 3 months, 6 months
3

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) .

Time frame
Change from Baseline immediately after the intervention
4

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.

Time frame
Change from Baseline immediately after the intervention

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)Recruiting70300, ZrifinIsraelIsrael

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assaf-Harofeh Medical Center

Lead sponsor

Source ClinicalTrials.gov
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