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Oxygen Therapy in Schizophrenia

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
Chronic Schizophrenia Drug: oxygen Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxygen Therapy in Schizophrenia
Study Start Date : January 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. PANSS [ Time Frame: every two weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impressions [ Time Frame: every two weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525863


Contacts
Contact: Yuly Bersudsky, MD, PhD yuly@bgu.ac.il

Locations
Israel
Beersheva Mental Health Center Recruiting
Beersheva, Israel
Contact: Yuly Bersudsky, MD, PhD    9728-6401602    yuly@bgu.ac.il   
Sponsors and Collaborators
Beersheva Mental Health Center
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Yuly Bersudsky, MD, PhD Ben-Gurion University of the Negev
More Information

Responsible Party: Yuly Bersudsky, Ben Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT00525863     History of Changes
Other Study ID Numbers: BMHC-4602
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: May 28, 2008
Last Verified: May 2008

Keywords provided by Beersheva Mental Health Center:
schizophrenia
oxygen therapy

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders