Oxygen Therapy in Schizophrenia

Chronic Schizophrenia Clinical Trial

Official title:

Oxygen Therapy in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00525863
• Other study ID #: BMHC-4602
• Status: Recruiting
• Phase: Phase 3
• First received: September 5, 2007
• Last updated: May 26, 2008
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2008
• Source: Beersheva Mental Health Center
• Contact: Yuly Bersudsky, MD, PhD
• Email: yuly[@]bgu.ac.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Schizophrenia
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Israel	Beersheva Mental Health Center	Beersheva

Sponsors (2)

Lead Sponsor	Collaborator
Beersheva Mental Health Center	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS		every two weeks
Secondary	Clinical Global Impressions		every two weeks