Oxygen Therapy in Depression

Study Overview
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Brief Summary
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The major objective of the present study is to examine the influence of normobaric hyperoxia treatment on the symptoms of patients diagnosed with depression members of Clalit Health Services. The investigators hypothesize that normobaric hyperoxia treatment will improve the symptoms of patients with depression.

Official Title
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Oxygen Therapy in Depression

Conditions
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Depression, Normobaric Hyperoxia.

Intervention / Treatment
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* Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18-65 years diagnosed with mild to moderate depression. Exclusion Criteria: Patients with oxygen saturation below 95%; An unstable mental (psychiatric) condition A psychiatric condition that requires a change in pharmacotherapy (importantly - medications will not be changed in patients who will be enrolled to the study) Acute or chronic respiratory disease Any severe physical illness Suicidal thoughts or attempts Drug abuse Obesity (BMI over 30) Inability to cease smoking during night hours while participants are supposed to be using the oxygen/air supplementing machine.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>One hundred participants will receive home treatment with oxygen-enriched air (40% O2) through a nasal tube during the night (7 hours) for one month. | Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression<br>* Forty percent oxygen or regular air will be supplied from oxygen concentrators, through standard plastic nasal prongs, at a flow rate of 5 liters/minute, for 7 hours a day, throughout the night.<br>* Other names: Oxygen-enriched air provided by oxygen concentrators to improve symptoms of patients with depression.;|
| Placebo Comparator: Placebo<br>100 participants will receive regular air treatment (21% O2) through a nasal tube (identical to the procedure providing 40% O2) for one month | Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression<br>* Forty percent oxygen or regular air will be supplied from oxygen concentrators, through standard plastic nasal prongs, at a flow rate of 5 liters/minute, for 7 hours a day, throughout the night.<br>* Other names: Oxygen-enriched air provided by oxygen concentrators to improve symptoms of patients with depression.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HRSD)-changes in patients' depression. | HRSD will be used to assess changes in patients' condition. Assessment will be performed at 3 time points: baseline (time zero), 2 weeks and 4 weeks after treatment initiation, by a trained psychiatric nurse blind to the patient's treatment status. | Baseline (time zero), 2 weeks and 4 weeks |