Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

NCT04368039 | Recruiting FDA Device

• 1 other identifier: 2019H0424
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia; First-episode Psychosis; Psychosis

Keywords

psychosis; treatment; normobaric hyperoxia

Outcome Measures

Primary Outcomes (5)

• Change from baseline in cognitive functioning

  Change in scores on the MATRICS Consensus Cognitive Battery (MCCB).

  4 weeks

• Change from baseline in quality of life

  Change in scores on WHO Quality of Life Scale Brief (WHOQOL-BREF.

  4 weeks

• 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

• 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

• Change from baseline in health-related quality of life

  Change in scores on the RAND 36-Item Health Survey.

  4 weeks

Secondary Outcomes (5)

• Change from baseline in suicidality

  4 weeks

• Change from baseline in substance use severity

  4 weeks

• Change from baseline in service utilization

  4 weeks

• Change in Sleep

  4 weeks

• Change from baseline in medication adherence

  4 weeks

Study Arms (2)

Normobaric Oxygen Therapy (40% FiO2)

EXPERIMENTAL

4 weeks of nightly normobaric oxygen therapy (40% FiO2)

Device: Normobaric Oxygen

Placebo Condition

PLACEBO COMPARATOR

4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)

Device: Placebo

Interventions

Normobaric Oxygen DEVICE

40% FiO2 for 4 weeks

Normobaric Oxygen Therapy (40% FiO2)

Placebo DEVICE

21% FiO2 for 4 weeks

Placebo Condition

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

* 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."

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nicholas Breitborde: lead

Study Sites (1)

Harding Hospital

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (20)

• 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.

  PMID: 15352925 BACKGROUND

• 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.

  PMID: 15038995 BACKGROUND

• 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.

  PMID: 17092996 BACKGROUND

• 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.

  PMID: 22722511 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 10867307 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22193671 BACKGROUND

• 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.

  PMID: 17715561 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 17151158 BACKGROUND

• 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.

  PMID: 18172019 BACKGROUND

• 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.

  PMID: 9626712 BACKGROUND

• 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.

  PMID: 10785582 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 3774930 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 15753237 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Nicholas Breitborde, PhD

CONTACT

(614) 685-6052; nicholas.breitborde@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: December 4, 2019
• Primary Completion (Estimated): December 7, 2026
• Study Completion (Estimated): December 7, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)