Oxygen Therapy in Depression | NCT02149563 | Trialant

Oxygen Therapy in Depression | NCT02149563 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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	Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxygen-enriched air -Normobaric hyperoxia treatment for depression	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34556722	Derived	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.