Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

Nicholas Breitborde20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Psychosis Schizophrenia First-episode Psychosis

Interventions

Normobaric OxygenDEVICE

40% FiO2 for 4 weeks

PlaceboDEVICE

21% FiO2 for 4 weeks

Eligibility

Sex: ALLMin age: 15 YearsMax age: 35 Years

Medical Language ↔ Plain English

* 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."

Locations (1)

Harding Hospital

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Change from baseline in cognitive functioning

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

Time frame: 4 weeks

Change from baseline in quality of life

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

Time frame: 4 weeks

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

Time frame: 4 weeks

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.

Time frame: 4 weeks

Change from baseline in health-related quality of life

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

Time frame: 4 weeks

Secondary Outcomes

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.

Time frame: 4 weeks

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)

Central Contacts

Nicholas Breitborde, PhD

CONTACT

(614) 685-6052 nicholas.breitborde@osumc.edu

Data from ClinicalTrials.gov

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