Oxygen Therapy in Schizophrenia
1 other identifier
interventional
20
1 country
1
Brief Summary
Due to intense ATP-consuming processes in the brain, a high level of brain energy supply is required. A popular hypothesis regarding the pathogenesis and pathophysiology of schizophrenia postulates hypofunction of neuronal circuits in the prefrontal and limbic-temporal areas. An emerging body of data suggests that impaired energy metabolism due to mitochondrial dysfunction plays a role in the pathophysiology of schizophrenia. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2007
CompletedFirst Posted
Study publicly available on registry
September 6, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMay 28, 2008
May 1, 2008
1.9 years
September 5, 2007
May 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PANSS
every two weeks
Secondary Outcomes (1)
Clinical Global Impressions
every two weeks
Interventions
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
You may qualify if:
- years old
- years of illness
- PANSS more than 60
You may not qualify if:
- unstable or serious physical illness
- suicidality
- drug abuse
- BMI above 30
- taking anti-hypertension medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beersheva Mental Health Center
Beersheva, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuly Bersudsky, MD, PhD
Ben-Gurion University of the Negev
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 5, 2007
First Posted
September 6, 2007
Study Start
January 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
May 28, 2008
Record last verified: 2008-05