RecruitingNot ApplicableNCT04368039

Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis


Sponsor

Nicholas Breitborde

Enrollment

20 participants

Start Date

Dec 4, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 15 YearsMax Age: 35 Years

Inclusion Criteria7

  • 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."

Interventions

DEVICENormobaric Oxygen

40% FiO2 for 4 weeks

DEVICEPlacebo

21% FiO2 for 4 weeks


Locations(1)

Harding Hospital

Columbus, Ohio, United States

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NCT04368039


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