Oxygen Therapy in Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Beersheva Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00525863
First received: September 5, 2007
Last updated: May 26, 2008
Last verified: May 2008

September 5, 2007
May 26, 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 ClinicalTrials.gov 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
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
Both
18 Years to 45 Years
No
Contact: Yuly Bersudsky, MD, PhD yuly@bgu.ac.il
Israel
 
NCT00525863
BMHC-4602
Yes
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