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
  Purpose

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 Intervention Phase
Chronic Schizophrenia
Drug: oxygen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxygen Therapy in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Beersheva Mental Health Center:

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

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

Estimated Enrollment: 20
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yuly Bersudsky, Ben Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT00525863     History of Changes
Other Study ID Numbers: BMHC-4602
Study First Received: September 5, 2007
Last Updated: May 26, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Beersheva Mental Health Center:
schizophrenia
oxygen therapy

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014