Active — Not RecruitingEarly Phase 1

Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

United States20 participantsStarted 2019-12-05

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient who meets DSM-V Criteria for MDD or Bipolar Depression (according to DSM-V), as the primary focus of treatment. * Able to understand the risks and benefits of participating in this clinical trial and give informed consent, per judgment of the investigator. * Age greater than or equal to 18 years but less than or equal to 65 years. * Montgomery Asberg Depression Rating Scale ≥20. * On an adequate antidepressant regimen (MDD) or on a mood stabilizing regimen (BP) that is stable for at least four weeks prior to enrollment. * Has reliable adult transportation from and to home. * Has a treating psychiatrist who is in agreement with the patient's participation in the study, and aware of the safety plan in the protocol. * No medical contraindications to receiving a xenon- or a nitrogen-oxygen mixture. * No serious or active pulmonary disease. Exclusion Criteria: * MDD or BP disorder with psychosis, schizophrenia, OCD, or a primary anxiety disorder. * Currently taking a benzodiazepine (including PRN). * Unwilling or unable to comply with study procedures. * Active substance abuse in the past 60 days, diagnosis of substance dependence in the past 12 months, currently active smokers of any substance, including prescription marijuana. * Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception. * Any unstable medical illness (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or he…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Depressive Symptoms

Timeframe: Improvement at day 1

Depressive Symptoms

Timeframe: Improvement at day 1

Trial details

NCT IDNCT03748446

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

View on ClinicalTrials.gov More Major Depressive Disorder trials