Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

Schizophrenia Clinical Trial

Official title:

Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368039
• Other study ID #: 2019H0424
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: December 7, 2025

Study information

• Verified date: July 2023
• Source: Ohio State University
• Contact: Nicholas Breitborde, PhD
• Phone: (614) 685-6052
• Email: nicholas.breitborde[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.

Description:

Functional deficits in prefrontal, limbic, and temporal regions of the brain are well-documented among individuals with psychotic disorders. Mitochondrial dysfunction may contribute to such pathology, and effective functioning of mitochondrial activity in the brain in dependent on a sufficient supply of oxygen. These data suggest that oxygen therapy may improve symptoms in individuals with psychosis. This small pilot study will test this hypothesis.

Individuals with first-episode psychosis will be randomized to receive either (i) 4 weeks of nightly normobaric oxygen therapy (40% FiO2) or (ii) 4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2). Participants will be blinded to what condition they receive. Both conditions will be delivered via nasal cannula connected to oxygen concentrators at five liters per minute (lpm), and participants will be instructed to complete the intervention overnight while sleeping. At the end of the 4 week period, all individuals will receive an additional 4 weeks of unblinded (i.e., "open label") nightly normobaric oxygen therapy (40% FiO2). Study assessments will be completed at (i) enrollment; (ii) 4 weeks after enrollment, and (iii) 8 weeks after enrollment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 7, 2025
• Est. primary completion date: December 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

• Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5.

• Less than 5 years since the onset of frank psychotic symptoms as determined using the Symptom Onset in Schizophrenia Inventory .

• No evidence of a pre-existing intellectual disability defined as a premorbid IQ >70 as estimated using the Reading subtest of the Wide Range Achievement Test-4.

• Ages 15-35

• Non-smoker for past six months

• Absence of suicidal ideation or behavior over the past month as assessed by the Columbia Suicide Severity Rating Scale

• The American Association for Respiratory Care notes that "no absolute contraindications to oxygen therapy exist when indications [for oxygen therapy] are present."

Related Conditions & MeSH terms

• First-episode Psychosis
• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizophrenia

Intervention

Device:
• Normobaric Oxygen
40% FiO2 for 4 weeks
• Placebo
21% FiO2 for 4 weeks

Locations

Country	Name	City	State
United States	Harding Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nicholas Breitborde

Country where clinical trial is conducted

United States, 

References & Publications (20)

AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007 Aug;52(8):1063-8. No abstract available. — View Citation

Auther, A., C. Smith, and B. Cornblatt, Global Functioning: Social Scale (GF: Social). Glen Oaks, NY: Zucker-Hillside Hospital, 2006.

Bloch Y, Applebaum J, Osher Y, Amar S, Azab AN, Agam G, Belmaker RH, Bersudsky Y. Normobaric hyperoxia treatment of schizophrenia. J Clin Psychopharmacol. 2012 Aug;32(4):525-30. doi: 10.1097/JCP.0b013e31825d70b8. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. — View Citation

Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667. — View Citation

First, M.B., et al., Structured Clinical Interview for DSM-5-Research Version2015, Arlington, VA: American Psychiatric Association.

Hays, R.D., S. Prince-Embury, and H.Y. Chen, RAND-36 Health Status Inventory1998, San Antonio, TX: The Psychological Corporation.

Hill K, Mann L, Laws KR, Stephenson CM, Nimmo-Smith I, McKenna PJ. Hypofrontality in schizophrenia: a meta-analysis of functional imaging studies. Acta Psychiatr Scand. 2004 Oct;110(4):243-56. doi: 10.1111/j.1600-0447.2004.00376.x. — View Citation

Kann O, Kovacs R. Mitochondria and neuronal activity. Am J Physiol Cell Physiol. 2007 Feb;292(2):C641-57. doi: 10.1152/ajpcell.00222.2006. Epub 2006 Nov 8. — View Citation

Karry R, Klein E, Ben Shachar D. Mitochondrial complex I subunits expression is altered in schizophrenia: a postmortem study. Biol Psychiatry. 2004 Apr 1;55(7):676-84. doi: 10.1016/j.biopsych.2003.12.012. — View Citation

Levine J, Schooler NR. SAFTEE: a technique for the systematic assessment of side effects in clinical trials. Psychopharmacol Bull. 1986;22(2):343-81. No abstract available. — View Citation

Niendam, T., et al., Global Functioning: Role Scale (GF: Role). Los Angeles, CA: University of California, Los Angeles, 2006.

Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD, Essock S, Fenton WS, Frese FJ 3rd, Gold JM, Goldberg T, Heaton RK, Keefe RS, Kraemer H, Mesholam-Gately R, Seidman LJ, Stover E, Weinberger DR, Young AS, Zalcman S, Marder SR. The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry. 2008 Feb;165(2):203-13. doi: 10.1176/appi.ajp.2007.07010042. Epub 2008 Jan 2. — View Citation

Palmer BA, Pankratz VS, Bostwick JM. The lifetime risk of suicide in schizophrenia: a reexamination. Arch Gen Psychiatry. 2005 Mar;62(3):247-53. doi: 10.1001/archpsyc.62.3.247. — View Citation

Perkins DO, Leserman J, Jarskog LF, Graham K, Kazmer J, Lieberman JA. Characterizing and dating the onset of symptoms in psychotic illness: the Symptom Onset in Schizophrenia (SOS) inventory. Schizophr Res. 2000 Jul 7;44(1):1-10. doi: 10.1016/s0920-9964(99)00161-9. — View Citation

Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704. — View Citation

Rosenheck RA, Leslie DL, Sindelar J, Miller EA, Lin H, Stroup TS, McEvoy J, Davis SM, Keefe RS, Swartz M, Perkins DO, Hsiao JK, Lieberman J; CATIE Study Investigators. Cost-effectiveness of second-generation antipsychotics and perphenazine in a randomized trial of treatment for chronic schizophrenia. Am J Psychiatry. 2006 Dec;163(12):2080-9. doi: 10.1176/ajp.2006.163.12.2080. — View Citation

Schizophrenia Spectrum and Other Psychotic Disorders, in DSM-5® Clinical Cases.

Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophr Res. 2000 May 5;42(3):241-7. doi: 10.1016/s0920-9964(99)00130-9. — View Citation

Wilkinson, G.S. and G.J. Robertson, Wide Range Achievement Test (WRAT4)2006, Lutz, FL: PAR, Inc.

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in cognitive functioning	Change in scores on the MATRICS Consensus Cognitive Battery (MCCB).	4 weeks
Primary	Change from baseline in quality of life	Change in scores on WHO Quality of Life Scale Brief (WHOQOL-BREF.	4 weeks
Primary	Change from baseline in social functioning	Change in scores on the Global Functioning: Social Scale. Scores on this measure range from 1-10 with higher scores indicating greater social functioning	4 weeks
Primary	Change from baseline in role functioning	Change in scores on the Global Functioning: Role Scale. Scores on this measure range from 1-10 with higher scores indicative of greater role functioning.	4 weeks
Primary	Change from baseline in health-related quality of life	Change in scores on the RAND 36-Item Health Survey.	4 weeks
Secondary	Change from baseline in suicidality	Change in occurrence in suicidal thoughts or behaviors as assessed using the Columbia Suicide Severity Rating Scale. This is a categorical rating scale that identifies the presence or absence of specific levels of severity of suicidal ideation and behavior.	4 weeks
Secondary	Change from baseline in substance use severity	Change in scores on the HABITS scale. This scale assesses the absolute values of use of specific substances (e.g., number of cigarettes smoked)	4 weeks
Secondary	Change from baseline in service utilization	Change in scores on the Modified Service Use and Resources Form for Schizophrenia	4 weeks
Secondary	Change in Sleep	Change in scores on the Pittsburgh Sleep Quality Index.	4 weeks
Secondary	Change from baseline in medication adherence	Change in scores on the Medication Adherence rating Scale. Scores on this scale range from 0-10 with higher scores indicative of greater medication adherence.	4 weeks