Oxygen therapy for people experiencing first-episode psychosis
Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis
This study is testing if breathing in extra oxygen at night can help people who are experiencing their first episode of psychosis feel better and think more clearly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 15 Years to 35 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT04368039 on ClinicalTrials.gov |
What this trial studies
This is a single-blind, randomized controlled trial investigating the effects of normobaric oxygen therapy on individuals with first-episode psychosis. Participants will be randomly assigned to receive either nightly oxygen therapy at 40% FiO2 or a placebo with room air at 21% FiO2 for four weeks. The study aims to assess changes in symptomatology and cognitive function, with evaluations conducted at enrollment, after four weeks, and after eight weeks. Following the initial phase, all participants will receive open-label oxygen therapy for an additional four weeks.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15-35 with a diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features who have experienced psychotic symptoms for less than five years.
Not a fit: Patients with a history of intellectual disability or those who have exhibited suicidal ideation or behavior in the past month may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve symptoms and cognitive function in individuals with first-episode psychosis.
How similar studies have performed: While the approach of using oxygen therapy for psychosis is novel, there is emerging evidence suggesting potential benefits of oxygen therapy in related conditions.
Eligibility criteria
Show full inclusion / exclusion 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."
Where this trial is running
Columbus, Ohio
- Harding Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Nicholas Breitborde, PhD
- Email: nicholas.breitborde@osumc.edu
- Phone: (614) 685-6052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.