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PsychosisNCT04368039

Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

A study testing Normobaric Oxygen in people with Psychosis and Schizophrenia, run by Nicholas Breitborde at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 15 to 35 years
Conditions the study is for
Psychosis, Schizophrenia, First-episode Psychosis
What is being tested?
Normobaric Oxygen
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 siteUnited States
Study dates
4 Dec 2019to 13 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult
  • 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."

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Harding Hospital

    Columbus, Ohio, 43210

Other trials in United States

About this study

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

Read the detailed 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.

Being tested
Normobaric Oxygen, Placebo
Keywords
psychosis, treatment, normobaric hyperoxia
Medical subject headings
Psychotic Disorders, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normobaric OxygenDevice

    40% FiO2 for 4 weeks

  • PlaceboDevice

    21% FiO2 for 4 weeks

Study groups in NCT04368039
Study groupRoleWhat they receive
Normobaric Oxygen Therapy (40% FiO2)Experimental4 weeks of nightly normobaric oxygen therapy (40% FiO2)
Receives: Device: Normobaric Oxygen
Placebo ConditionPlacebo comparator4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)
Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in cognitive functioning

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

    Measured: 4 weeks

  2. Change from baseline in quality of life

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

    Measured: 4 weeks

  3. 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

    Measured: 4 weeks

  4. 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.

    Measured: 4 weeks

  5. Change from baseline in health-related quality of life

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

    Measured: 4 weeks

Secondary outcomes (5)

  1. 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.

    Measured: 4 weeks

  2. 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)

    Measured: 4 weeks

  3. Change from baseline in service utilization

    Change in scores on the Modified Service Use and Resources Form for Schizophrenia

    Measured: 4 weeks

  4. Change in Sleep

    Change in scores on the Pittsburgh Sleep Quality Index.

    Measured: 4 weeks

  5. 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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start4 Dec 2019
  3. Primary completion13 Oct 2026
  4. Study completion13 Oct 2026

Why it stopped: Vendor unable to continue to provide oxygen concentrators

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04368039
Sponsor's protocol ID
2019H0424
Status last verified
Oct 2026
First submitted
27 Apr 2020
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 15352925

  • 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.

    PubMed 15038995

  • 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.

    PubMed 17092996

  • 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.

    PubMed 22722511

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

  • 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.

    PubMed 10867307

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

  • 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.

    PubMed 22193671

  • 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.

    PubMed 17715561

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

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

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

  • 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.

    PubMed 17151158

  • 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.

    PubMed 18172019

  • 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.

    PubMed 9626712

Questions about this trial

What is this clinical trial studying?

A study testing Normobaric Oxygen in people with Psychosis and Schizophrenia, run by Nicholas Breitborde at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Vendor unable to continue to provide oxygen concentrators). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in cognitive functioning (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04368039, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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