Oxygen Therapy in Depression

March 15, 2015 updated by: Meir Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-sheva, Israel
        • Recruiting
        • Clalit Health Services in the Southern region
        • Contact:
          • Pesach Shvartzman, M.D.
          • Phone Number: 972-8-6477429

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Oxygen-enriched air provided by oxygen concentrators to improve symptoms of patients with depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (time zero), 2 weeks and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

May 25, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 15, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression, Normobaric Hyperoxia.

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