Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis
NCT ID: NCT04368039
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2019-12-04
2025-12-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Normobaric Oxygen Therapy (40% FiO2)
4 weeks of nightly normobaric oxygen therapy (40% FiO2)
Normobaric Oxygen
40% FiO2 for 4 weeks
Placebo Condition
4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)
Placebo
21% FiO2 for 4 weeks
Interventions
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Normobaric Oxygen
40% FiO2 for 4 weeks
Placebo
21% FiO2 for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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."
15 Years
35 Years
ALL
No
Sponsors
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Nicholas Breitborde
OTHER
Responsible Party
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Nicholas Breitborde
Principal Investigator
Locations
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Harding Hospital
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hays, R.D., S. Prince-Embury, and H.Y. Chen, RAND-36 Health Status Inventory1998, San Antonio, TX: The Psychological Corporation.
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.
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.
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.
Other Identifiers
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2019H0424
Identifier Type: -
Identifier Source: org_study_id
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