Oxygen Therapy in Schizophrenia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 5, 2007

Last Updated Date

May 26, 2008

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PANSS [ Time Frame: every two weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00525863 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical Global Impressions [ Time Frame: every two weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Oxygen Therapy in Schizophrenia

Official Title ^ICMJE

Oxygen Therapy in Schizophrenia

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Schizophrenia

Intervention ^ICMJE

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.

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yuly Bersudsky, MD, PhD

yuly@bgu.ac.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00525863

Responsible Party

Yuly Bersudsky, Ben Gurion University of the Negev

Study ID Numbers ^ICMJE

BMHC-4602

Study Sponsor ^ICMJE

Beersheva Mental Health Center

Collaborators ^ICMJE

National Alliance for Research on Schizophrenia and Depression

Investigators ^ICMJE

Principal Investigator:

Yuly Bersudsky, MD, PhD

Ben-Gurion University of the Negev

Information Provided By

Beersheva Mental Health Center

Verification Date

May 2008

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