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NCT03748446 · ClinicalTrials.gov registry record · Early Phase 1
Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder
A Early Phase 1 study of Major Depressive Disorder and Bipolar Depression, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03748446: Recruiting Early Phase 1 study of Major Depressive Disorder and Bipolar Depression, sponsored by Massachusetts General Hospital.
NCT03748446 is a Early Phase 1 study of Major Depressive Disorder and Bipolar Depression that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03748446, a Early Phase 1 study of Major Depressive Disorder and Bipolar Depression, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Hamilton Depression Rating Scale (HDRS):This scale is a 6-item survey which is one of the most frequently used instruments for evaluating depression in adults, the questionnaire allows clinicians to assess the nature and severity of mood disorders in patient populations. Score Range: 0-42, higher scores means worse outcomes
Conditions Studied
Interventions
- DRUG Xenon
- DRUG Nitrogen gas
Study Locations (1)
Massachusetts
- Dauten Family Center for Bipolar Treatment Innovation - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-12-05 |
| Est. Completion | 2026-12-01 |
| Phase | Early Phase 1 |
What NCT03748446 shows while recruiting
NCT03748446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Xenon is the first listed.
NCT03748446 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03748446 about?
NCT03748446 is a clinical study titled "Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder". 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 effe...
What is the current status of trial NCT03748446?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2019-12-05. Estimated completion is 2026-12-01.
What conditions does trial NCT03748446 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Bipolar Depression.
What interventions are being tested in trial NCT03748446?
The interventions under investigation include: Xenon (DRUG), Nitrogen gas (DRUG).
Who is sponsoring clinical trial NCT03748446?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03748446 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03748446's enrollment target sits among peer trials
20 243rd of 282 higher than 34 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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