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NCT02149563 Clinical Trial

Oxygen Therapy in Depression

Depression, Normobaric Hyperoxia. Clinical Trial

Official title:
Oxygen Therapy in Depression

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02149563
Other study ID # 002
Secondary ID
Status Recruiting
Phase N/A
First received April 7, 2014
Last updated March 15, 2015
Start date January 2015
Est. completion date September 2016

Study information
Verified date March 2015
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Israel Clalit Health Services in the Southern region Beer-sheva

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No