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)
View Full Details on ClinicalTrials.gov
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NCT04368039
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