Oxygen Therapy in Depression

• ClinicalTrials.gov Identifier: NCT02149563
• Recruitment Status: Unknown
• First Posted: May 29, 2014
• Last Update Posted: March 17, 2015
• Sponsor: Meir Medical Center
• Information provided by (Responsible Party): Meir Medical Center

Tracking Information

• First Submitted Date: April 7, 2014
• First Posted Date: May 29, 2014
• Last Update Posted Date: March 17, 2015
• Study Start Date: January 2015
• Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2014)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oxygen Therapy in Depression
• Official Title: Oxygen Therapy in Depression
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Depression, Normobaric Hyperoxia.

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.

Other Name: Oxygen-enriched air provided by oxygen concentrators to improve symptoms of patients with depression.

Study Arms

• 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.
  Intervention: Device: oxygen-enriched air -Normobaric hyperoxia treatment for 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
  Intervention: Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 25, 2014): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2016
• Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT02149563
• Other Study ID Numbers: 002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Meir Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Meir Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Meir Medical Center
• Verification Date: March 2015