Back to resultsOxygen Therapy in Depression
Primary Purpose
Depression, Normobaric Hyperoxia.
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
oxygen-enriched air -Normobaric hyperoxia treatment for depression
Sponsored by
About this trial
This is an interventional treatment trial for Depression, Normobaric Hyperoxia.
Eligibility 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.
Sites / Locations
- Clalit Health Services in the Southern regionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
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.
100 participants will receive regular air treatment (21% O2) through a nasal tube (identical to the procedure providing 40% O2) for one month
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02149563
Brief Title
Oxygen Therapy in Depression
Official Title
Oxygen Therapy in Depression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Normobaric Hyperoxia.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 participants will receive regular air treatment (21% O2) through a nasal tube (identical to the procedure providing 40% O2) for one month
Intervention Type
Device
Intervention Name(s)
oxygen-enriched air -Normobaric hyperoxia treatment for depression
Other Intervention Name(s)
Oxygen-enriched air provided by oxygen concentrators to improve symptoms of patients with depression.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HRSD)-changes in patients' depression.
Description
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.
Time Frame
Baseline (time zero), 2 weeks and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Clalit Health Services in the Southern region
City
Beer-sheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pesach Shvartzman, M.D.
Phone
972-8-6477429
12. IPD Sharing Statement
Citations:
PubMed Identifier
34556722
Citation
Bloch Y, Belmaker RH, Shvartzman P, Romem P, Bolotin A, Bersudsky Y, Azab AN. Normobaric oxygen treatment for mild-to-moderate depression: a randomized, double-blind, proof-of-concept trial. Sci Rep. 2021 Sep 23;11(1):18911. doi: 10.1038/s41598-021-98245-9.
Results Reference
derived
Learn more about this trial
Oxygen Therapy in Depression
We'll reach out to this number within 24 hrs