Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
20 participants
INTERVENTIONAL
2008-01-31
2009-12-31
Brief Summary
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Under normal conditions cellular metabolic rate, i.e. oxygen and glucose consumption, increases proportionally with any increase in neuronal activity. The impaired energy metabolism due to mitochondrial dysfunction and frontal lobe hypofunction might be improved by increasing O2 supply to the brain. Oxygen-enriched air inhalation has been shown to increase brain oxygen supply. Hyperoxia therapy is a useful tool in the treatment of neurological and neurotrauma deficits.
We therefore suggest a randomized double blind cross-over study of enriched inspired O2 partial pressure in schizophrenia.
It is surprising given the numerous findings on reduced energy metabolism in schizophrenia that simple treatment with inspired enriched oxygen has not been studied.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Interventions
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oxygen
Patients will be treated with oxygen for 1 month and then for 1 month with regular air with the same flow rate and procedure or randomly in the opposite order. We propose to enrich the inspired oxygen partial pressure from 21 kPA to \~40 kPa in a double blind cross-over design. Ninety percent oxygen or regular air will be supplied from oxygen concentrators, through standard plastic nasal prongs, at a flow rate of 5 liters/minute, for 7 hours/day, throughout the night.
Eligibility Criteria
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Inclusion Criteria
* 2 years of illness
* PANSS more than 60
Exclusion Criteria
* suicidality
* drug abuse
* BMI above 30
* taking anti-hypertension medication
18 Years
45 Years
ALL
No
Sponsors
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National Alliance for Research on Schizophrenia and Depression
OTHER
Beersheva Mental Health Center
OTHER_GOV
Responsible Party
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Ben Gurion University of the Negev
Principal Investigators
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Yuly Bersudsky, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ben-Gurion University of the Negev
Locations
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Beersheva Mental Health Center
Beersheva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Yuly Bersudsky, MD, PhD
Role: primary
Other Identifiers
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BMHC-4602
Identifier Type: -
Identifier Source: org_study_id