CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Active· 20 target
Drug / intervention
Xenon +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03748446
NCT03748446Early Ph 1ActiveOn Track
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Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

Massachusetts General Hospital·interventional·Posted Nov 20, 2018·Updated Jun 23, 2026

In Brief

A Early Phase 1 clinical trial evaluating Xenon and Nitrogen gas for Major Depressive Disorder and Bipolar Depression. Active but no longer recruiting, targeting 20 participants across 1 site.

Detailed Summary

The investigators will test the hypothesis that inhaled xenon will produce a rapid improvement in depressive symptoms in patients suffering from treatment-resistant depression. Specifically, the investigators will conduct a parallel randomized, double-blind crossover study that will compare the effects of xenon-oxygen (35:65 ratio by volume) added to treatment as usual (X-TAU group) to the effects of nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group). A total of 20 severely depressed patients, 10 with major depressive disorder (MDD) and 10 with Bipolar Depression (BP), will be exposed in random order to N-TAU and X-TAU in a double-blind protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, Bipolar Depression
CountriesUnited States
Collaborators--

Timeline

Early Ph 1Active
201920202021202220232024202520262027
First PostedNov 20, 2018
Enrollment StartDec 5, 2019
Primary CompletionSep 1, 2026
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 7.6 years agoPrimary completion in 2 months

Arms & Interventions

X-TAU (xenon)active_comparator

Xenon is a potent antiglutaminergic agent that has been used as an anesthetic with minimal side effects, has neuroprotective effects consistent with antidepressants and has the potential to be a novel antidepressant drug. \- xenon-oxygen (35:65 ratio by volume) added to treatment as usual (X-TAU group)

Drug: Xenon
N-TAU (nitrogen-placebo)placebo_comparator

Nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group)

Drug: Nitrogen gas

Interventions

Xenondrug

The investigators have chosen to use as a maximum concentration about half the general anesthetic partial pressure of xenon (35%=70%/2) to achieve a dose that is sub-anesthetic. This concentration of xenon is very close to that at which subjects emerging from xenon anesthesia first respond to verbal commands, commonly referred to as MAC awake.

Nitrogen gasdrug

nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual