Oxygen Therapy in Schizophrenia - Full Text View

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 III

MedlinePlus related topics:

Schizophrenia

ChemIDplus related topics:

Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	Oxygen Therapy in Schizophrenia

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:

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

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

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

Keywords provided by Beersheva Mental Health Center:

schizophrenia

oxygen therapy

Study placed in the following topic categories:

Schizophrenia

Mental Disorders

Salicylsalicylic acid

Sodium Salicylate

Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 29, 2008

Sponsors and Collaborators:	Beersheva Mental Health Center National Alliance for Research on Schizophrenia and Depression
Information provided by:	Beersheva Mental Health Center
ClinicalTrials.gov Identifier:	NCT00525863