Depression, Normobaric Hyperoxia.NCT02149563
Oxygen Therapy in Depression
A study testing oxygen-enriched air -Normobaric hyperoxia treatment for depression in people with Depression, Normobaric Hyperoxia., run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Normobaric Hyperoxia.
- What is being tested?
- oxygen-enriched air -Normobaric hyperoxia treatment for depression
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-65 years diagnosed with mild to moderate depression.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Clalit Health Services in the Southern region
Beersheba
Pesach Shvartzman, M.D., 972-8-6477429
About this study
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.
- Conditions
- Depression, Normobaric Hyperoxia.
- Being tested
- oxygen-enriched air -Normobaric hyperoxia treatment for depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen-enriched air -Normobaric hyperoxia treatment for depressionDevice
Also called Oxygen-enriched air provided by oxygen concentrators to improve symptoms of patients with 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | 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. Receives: Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression |
| Placebo | Placebo comparator | 100 participants will receive regular air treatment (21% O2) through a nasal tube (identical to the procedure providing 40% O2) for one month Receives: Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (time zero), 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, Normobaric Hyperoxia.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149563
- Sponsor's protocol ID
- 002
- Status last verified
- Mar 2015
- First submitted
- 7 Apr 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 34556722
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Therapy in Depression
- ClinicalTrials.gov ID
- NCT02149563
- Acronym / sponsor ID
- 002
- Conditions
- Depression, Normobaric Hyperoxia.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: oxygen-enriched air -Normobaric hyperoxia treatment for depressionOne hundred participants will receive home treatment with oxygen-enriched air (40% O2) through a nasal tube during the night (7 hours) for one month. |
| Placebo | Placebo comparator | Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression100 participants will receive regular air treatment (21% O2) through a nasal tube (identical to the procedure providing 40% O2) for one month |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged 18-65 years diagnosed with mild to moderate depression.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen-enriched air -Normobaric hyperoxia treatment for depressionAlso: Oxygen-enriched air provided by oxygen concentrators to improve symptoms of patients with 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. | Device | Placebo, Treatment |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Derived from this study: PubMed 34556722Bloch 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxygen-enriched air -Normobaric hyperoxia treatment for depression in people with Depression, Normobaric Hyperoxia., run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (HRSD)-changes in patients' depression. (time frame: Baseline (time zero), 2 weeks and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02149563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.