Status:

RECRUITING

Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

Lead Sponsor:

Nicholas Breitborde

Conditions:

Psychosis

Schizophrenia

Eligibility:

All Genders

15-35 years

Phase:

NA

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,...

Eligibility Criteria

Inclusion

  • 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."

Exclusion

    Key Trial Info

    Start Date :

    December 4 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 7 2025

    Estimated Enrollment :

    20 Patients enrolled

    Trial Details

    Trial ID

    NCT04368039

    Start Date

    December 4 2019

    End Date

    December 7 2025

    Last Update

    October 30 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Harding Hospital

    Columbus, Ohio, United States, 43210