Clinical trial NCT04368039: Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis
Official title: Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Schizophrenia
First-episode Psychosis
Keywords: psychosis
treatment
normobaric hyperoxia
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: * 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."

Primary outcomes:
measure: Change from baseline in cognitive functioning
timeFrame: 4 weeks
measure: Change from baseline in quality of life
timeFrame: 4 weeks
measure: Change from baseline in social functioning
timeFrame: 4 weeks
measure: Change from baseline in role functioning
timeFrame: 4 weeks
measure: Change from baseline in health-related quality of life
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline in suicidality
timeFrame: 4 weeks
measure: Change from baseline in substance use severity
timeFrame: 4 weeks
measure: Change from baseline in service utilization
timeFrame: 4 weeks
measure: Change in Sleep
timeFrame: 4 weeks
measure: Change from baseline in medication adherence
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Harding Hospital
state: Ohio
Study officials:
References:
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