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Normobaric Oxygen Therapy for First-Episode Psychosis
N/A
Recruiting
Research Sponsored by Nicholas Breitborde
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5.
Ages 15-35
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Summary
This trial found that normobaric oxygen therapy had no effect on symptoms or cognition in people with first-episode psychosis.
Who is the study for?
This trial is for young adults aged 15-35 who have recently experienced their first episode of psychosis, specifically schizophrenia or mood disorders with psychotic features. Participants must be non-smokers without suicidal thoughts in the past month and have an IQ above 70.Check my eligibility
What is being tested?
The study is testing if breathing normobaric oxygen can help with symptoms and thinking abilities in people with first-time psychosis. It's a single-blind trial where some get real oxygen therapy and others get a placebo, decided randomly.See study design
What are the potential side effects?
While specific side effects are not listed, normobaric oxygen therapy is generally considered safe. However, potential side effects could include mild discomfort or nasal dryness from the oxygen delivery system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia or a mood disorder with psychosis.
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I am between 15 and 35 years old.
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I have been diagnosed with schizophrenia or a mood disorder with psychosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in cognitive functioning
Change from baseline in health-related quality of life
Change from baseline in quality of life
+2 moreSecondary outcome measures
Change from baseline in medication adherence
Change from baseline in service utilization
Change from baseline in substance use severity
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Normobaric Oxygen Therapy (40% FiO2)Experimental Treatment1 Intervention
4 weeks of nightly normobaric oxygen therapy (40% FiO2)
Group II: Placebo ConditionPlacebo Group1 Intervention
4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)
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Who is running the clinical trial?
Nicholas BreitbordeLead Sponsor
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with schizophrenia or a mood disorder with psychosis.You do not have a pre-existing intellectual disability, which means your IQ was measured to be above 70 before you got sick.My psychotic symptoms started less than 5 years ago.You haven't smoked in the past six months.You have not had thoughts of harming yourself, and you have not attempted to harm yourself in the past month.I am between 15 and 35 years old.I have been diagnosed with schizophrenia or a mood disorder with psychosis.You have experienced severe symptoms of a mental illness called schizophrenia less than 5 years ago.I can receive oxygen therapy if needed.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Condition
- Group 2: Normobaric Oxygen Therapy (40% FiO2)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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