Oxygen Therapy in Schizophrenia
Primary Purpose
Chronic Schizophrenia
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Schizophrenia focused on measuring schizophrenia, oxygen therapy
Eligibility Criteria
Inclusion Criteria:
- 18-45 years old
- 2 years of illness
- PANSS more than 60
Exclusion Criteria:
- unstable or serious physical illness
- suicidality
- drug abuse
- BMI above 30
- taking anti-hypertension medication
Sites / Locations
- Beersheva Mental Health CenterRecruiting
Outcomes
Primary Outcome Measures
PANSS
Secondary Outcome Measures
Clinical Global Impressions
Full Information
NCT ID
NCT00525863
First Posted
September 5, 2007
Last Updated
May 26, 2008
Sponsor
Beersheva Mental Health Center
Collaborators
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT00525863
Brief Title
Oxygen Therapy in Schizophrenia
Official Title
Oxygen Therapy in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Beersheva Mental Health Center
Collaborators
National Alliance for Research on Schizophrenia and Depression
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Schizophrenia
Keywords
schizophrenia, oxygen therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
PANSS
Time Frame
every two weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impressions
Time Frame
every two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-45 years old
2 years of illness
PANSS more than 60
Exclusion Criteria:
unstable or serious physical illness
suicidality
drug abuse
BMI above 30
taking anti-hypertension medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuly Bersudsky, MD, PhD
Email
yuly@bgu.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuly Bersudsky, MD, PhD
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beersheva Mental Health Center
City
Beersheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuly Bersudsky, MD, PhD
Phone
9728-6401602
Email
yuly@bgu.ac.il
12. IPD Sharing Statement
Learn more about this trial
Oxygen Therapy in Schizophrenia
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