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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

Study 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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

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 more

Secondary outcome measures

Change from baseline in medication adherence

Change from baseline in service utilization

Change from baseline in substance use severity

+2 more

Trial 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)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nicholas BreitbordeLead Sponsor

1 Previous Clinical Trials

Media Library

Normobaric Oxygen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04368039 — N/A

First Episode Psychosis Research Study Groups: Placebo Condition, Normobaric Oxygen Therapy (40% FiO2)

First Episode Psychosis Clinical Trial 2023: Normobaric Oxygen Highlights & Side Effects. Trial Name: NCT04368039 — N/A

Normobaric Oxygen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04368039 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join the investigation?

"Candidates between the ages of 15 and 35, with a diagnosis of psychosis, are eligible to join this clinical trial. Approximately 20 people will be permitted to partake in the experiment."

Answered by AI

What is the primary objective of this experiment?

"This 4-week medical study chiefly evaluates the alteration in role functioning from baseline. Secondary goals include monitoring service utilization, suicidality, and substance use severity; all of which are measured using distinct rating systems like the Modified Service Use and Resources Form for Schizophrenia, Columbia Suicide Severity Rating Scale, and HABITS scale respectively."

Answered by AI

Are participants over fifty years of age being considered for this research project?

"According to the inclusionary stipulations of this medical trial, participants must be between 15 and 35 years of age. There are 138 studies for minors (under 18) and 365 specifically targeting seniors above 65."

Answered by AI

Is recruitment for this trial still open?

"Information on clinicaltrials.gov confirms that the enlistment of patients for this experiment is ongoing, with an initial posting date of December 4th 2019 and latest edit occuring April 18th 2022."

Answered by AI

How many individuals are currently participating in this research?

"Affirmative. Clinicaltrials.gov shows that this experiment is presently recruiting participants, which were first mentioned on December 4th 2019 and recently modified on April 18th 2022. There are a total of 20 patients required to be enrolled from 1 research site."

Answered by AI

Recent research and studies

Schizophrenia ResearchJournal

Characterizing and Dating the Onset of Symptoms in Psychotic Illness: The Symptom Onset in Schizophrenia (SOS) Inventory

Perkins, Diana O., Jane Leserman, L.Fredrik Jarskog, Karen Graham, Janet Kazmer, and Jeffrey A. Lieberman. 2000. “Characterizing and Dating the Onset of Symptoms in Psychotic Illness: The Symptom Onset in Schizophrenia (SOS) Inventory”. Schizophrenia Research. Elsevier BV. doi:10.1016/s0920-9964(99)00161-9.

Journal of Clinical PsychopharmacologyJournal

Normobaric Hyperoxia Treatment of Schizophrenia

Bloch, Yehudit, Julia Applebaum, Yamima Osher, Shirly Amar, Abed N. Azab, Galila Agam, R. H. Belmaker, and Yuly Bersudsky. 2012. “Normobaric Hyperoxia Treatment of Schizophrenia”. Journal of Clinical Psychopharmacology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/jcp.0b013e31825d70b8.

American Journal of PsychiatryJournal

The Columbia–suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings from Three Multisite Studies with Adolescents and Adults

Posner, Kelly, Gregory K. Brown, Barbara Stanley, David A. Brent, Kseniya V. Yershova, Maria A. Oquendo, Glenn W. Currier, et al.. 2011. “The Columbia–suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings from Three Multisite Studies with Adolescents and Adults”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/appi.ajp.2011.10111704.

Schizophrenia ResearchJournal