Oxygen Therapy in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525863
Recruitment Status : Unknown
Verified May 2008 by Beersheva Mental Health Center.
Recruitment status was:  Recruiting
First Posted : September 6, 2007
Last Update Posted : May 28, 2008
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Beersheva Mental Health Center

September 5, 2007
September 6, 2007
May 28, 2008
January 2008
December 2009   (Final data collection date for primary outcome measure)
PANSS [ Time Frame: every two weeks ]
Same as current
Complete list of historical versions of study NCT00525863 on Archive Site
Clinical Global Impressions [ Time Frame: every two weeks ]
Same as current
Not Provided
Not Provided
Oxygen Therapy in Schizophrenia
Oxygen Therapy in Schizophrenia

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.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Schizophrenia
Drug: 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.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Yuly Bersudsky, Ben Gurion University of the Negev
Beersheva Mental Health Center
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Yuly Bersudsky, MD, PhD Ben-Gurion University of the Negev
Beersheva Mental Health Center
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP