Oxygen Therapy in Depression

Not Applicable

• Conditions: Depression, Normobaric Hyperoxia.
• Interventions: Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression

• Registration Number: NCT02149563
• Lead Sponsor: Meir Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-05-25
• Study First Posted: 2014-05-29
• Study Start: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-15
• Last Update Posted: 2015-03-17
• Primary Completion: 2016-04
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Men and women aged 18-65 years diagnosed with mild to moderate depression.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	oxygen-enriched air -Normobaric hyperoxia treatment for depression	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.
Placebo	oxygen-enriched air -Normobaric hyperoxia treatment for depression	100 participants will receive regular air treatment (21% O2) through a nasal tube (identical to the procedure providing 40% O2) for one month

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HRSD)-changes in patients' depression.	Baseline (time zero), 2 weeks and 4 weeks	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.

Trial Locations

Locations (1)

Clalit Health Services in the Southern region; 🇮🇱 Beer-sheva, Israel