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Oxygen Therapy in Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02149563
Recruitment Status : Unknown
Verified March 2015 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : May 29, 2014
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression, Normobaric Hyperoxia. Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Oxygen Therapy in Depression
Study Start Date : January 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment
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
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.
Other Name: Oxygen-enriched air provided by oxygen concentrators to improve symptoms of patients with depression.
Placebo Comparator: Placebo
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
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.
Other Name: Oxygen-enriched air provided by oxygen concentrators to improve symptoms of patients with depression.


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HRSD)-changes in patients' depression. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149563


Locations
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Israel
Clalit Health Services in the Southern region Recruiting
Beer-sheva, Israel
Contact: Pesach Shvartzman, M.D.    972-8-6477429      
Sponsors and Collaborators
Meir Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02149563    
Other Study ID Numbers: 002
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Hyperoxia
Depression
Depressive Disorder
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Signs and Symptoms, Respiratory