NCT04368039 · Nicholas Breitborde
Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis
What this study is about
Single-blind, randomly assigned controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.
View original scientific description
Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.
Interventions
DEVICE
Normobaric Oxygen
40% FiO2 for 4 weeks
DEVICE
Placebo
21% FiO2 for 4 weeks
Primary outcome measures
Change from baseline in cognitive functioning
Time frame: 4 weeks
Change in scores on the MATRICS Consensus Cognitive Battery (MCCB).
Change from baseline in quality of life
Time frame: 4 weeks
Change in scores on WHO Quality of Life Scale Brief (WHOQOL-BREF.
Change from baseline in social functioning
Time frame: 4 weeks
Change in scores on the Global Functioning: Social Scale. Scores on this measure range from 1-10 with higher scores indicating greater social functioning
Change from baseline in role functioning
Time frame: 4 weeks
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.
Change from baseline in health-related quality of life
Time frame: 4 weeks
Change in scores on the RAND 36-Item Health Survey.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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.
- 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
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2026 · Source of record for eligibility and locations