RecruitingEarly Phase 1NCT03748446

Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder


Sponsor

Massachusetts General Hospital

Enrollment

20 participants

Start Date

Dec 5, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether breathing a small amount of xenon gas (an inert gas with possible mood-stabilizing properties) can help relieve depression in people with major depressive disorder (MDD) or bipolar disorder. **You may be eligible if...** - You have been diagnosed with major depressive disorder or bipolar depression (per standard diagnostic criteria) - You are aged 18–65 years - Your depression score on a standardized scale is 20 or above (indicating moderate-to-severe depression) - You have been on a stable antidepressant or mood stabilizer for at least 4 weeks - You have reliable transportation to and from the clinic after treatments **You may NOT be eligible if...** - You are not currently on medication for your depression or bipolar disorder - You have a history of psychosis or active suicidal intent - You have severe lung or breathing problems - You are pregnant or breastfeeding - You have had recent changes in your psychiatric medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXenon

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.

DRUGNitrogen gas

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


Locations(1)

Dauten Family Center for Bipolar Treatment Innovation

Boston, Massachusetts, United States

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NCT03748446


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