Health TrialsbyHealthPanel

Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

ConditionsPsychosisSchizophreniaFirst-episode Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-35
SponsorNicholas Breitborde

About this trial

Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Normobaric Oxygen

    Device

    40% FiO2 for 4 weeks

  • Placebo

    Device

    21% FiO2 for 4 weeks

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Normobaric Oxygen Therapy (40% FiO2)Experimental treatment 1 intervention
Group B: Placebo ConditionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in cognitive functioning

Change in scores on the MATRICS Consensus Cognitive Battery (MCCB).

Time frame
4 weeks
2

Change from baseline in quality of life

Change in scores on WHO Quality of Life Scale Brief (WHOQOL-BREF.

Time frame
4 weeks
3

Change from baseline in social functioning

Change in scores on the Global Functioning: Social Scale. Scores on this measure range from 1-10 with higher scores indicating greater social functioning

Time frame
4 weeks
4

Change from baseline in role functioning

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.

Time frame
4 weeks

Secondary outcomes

1

Change from baseline in suicidality

Change in occurrence in suicidal thoughts or behaviors as assessed using the Columbia Suicide Severity Rating Scale. This is a categorical rating scale that identifies the presence or absence of specific levels of severity of suicidal ideation and behavior.

Time frame
4 weeks
2

Change from baseline in substance use severity

Change in scores on the HABITS scale. This scale assesses the absolute values of use of specific substances (e.g., number of cigarettes smoked)

Time frame
4 weeks
3

Change from baseline in service utilization

Change in scores on the Modified Service Use and Resources Form for Schizophrenia

Time frame
4 weeks
4

Change in Sleep

Change in scores on the Pittsburgh Sleep Quality Index.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicholas Breitborde

Lead sponsor

Ohio State University

Sponsor institution

Source ClinicalTrials.gov
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