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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03748446
The ClinicalTrials.gov registry entry for NCT03748446 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (95% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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