20 Participants Needed

Xenon Inhalation Therapy for Depression

SA
AN
Overseen ByAndrew Nierenberg, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Massachusetts General Hospital
Must be taking: Antidepressants, Mood stabilizers

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if inhaling a gas called xenon can quickly reduce symptoms in people with depression that hasn't improved with other treatments. Researchers will study two groups: one will inhale a mixture of xenon and oxygen, and the other will inhale a mixture of nitrogen and oxygen, both added to their usual treatment. People with severe depression, whether major depressive disorder or bipolar depression, who have a stable medication plan and no serious lung issues, might be a good fit for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this novel approach.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. However, you must be on a stable antidepressant or mood stabilizing regimen for at least four weeks before joining the study. You cannot participate if you are currently taking benzodiazepines.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Xenon inhalation therapy is usually well tolerated by patients. In a study on panic disorder, side effects such as headache and dizziness were uncommon, and only a few participants withdrew because of them. This suggests that Xenon might also be safe for individuals with depression. Another study found that Xenon could help lessen depressive symptoms, although it has not been definitively proven as an antidepressant yet. Based on these findings, Xenon appears to be a promising and safe option for those with depression who have not found relief with other treatments.12345

Why do researchers think this study treatment might be promising for depression?

Researchers are excited about Xenon Inhalation Therapy for depression because it introduces a unique way to tackle the condition. Unlike standard treatments like SSRIs and SNRIs, which adjust serotonin or norepinephrine levels, xenon works as a potent antiglutaminergic agent, potentially offering neuroprotective effects. This novel mechanism might provide antidepressant benefits with minimal side effects, setting it apart from typical medications. Additionally, xenon's anesthetic properties might deliver quicker relief, offering a promising new option for those who do not respond well to existing treatments.

What evidence suggests that xenon inhalation therapy might be an effective treatment for depression?

Research suggests that inhaling xenon gas, which participants in this trial may receive, might help reduce symptoms of depression, particularly for those who haven't found relief with other treatments. Xenon blocks certain signals in the brain, similar to the function of some antidepressants. Studies have shown that xenon has been safely used as an anesthetic, and its protective effects on the brain resemble those of antidepressants. Other research indicates that xenon might also help with panic disorders, suggesting potential benefits for depression. Although data remains in the early stages, this therapy shows promise for those with treatment-resistant depression. Participants in this trial may also receive nitrogen gas as a placebo comparator.12367

Who Is on the Research Team?

AN

Andrew Nierenberg, MD

Principal Investigator

Massachussetts General Hospital

Are You a Good Fit for This Trial?

Adults aged 18-65 with severe depression or bipolar disorder, who haven't responded to standard treatments, can join. They must understand the trial and consent, have stable medication for four weeks, reliable transport, and a psychiatrist's approval. Pregnant women, active substance abusers, smokers, those with certain medical conditions or taking benzodiazepines are excluded.

Inclusion Criteria

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.
I do not have any serious lung conditions.
I have been on a stable antidepressant or mood stabilizer for over 4 weeks.
See 5 more

Exclusion Criteria

I am currently taking a benzodiazepine medication.
I do not have any uncontrolled serious health conditions.
Unwilling or unable to comply with study procedures.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one session of xenon inhalation and one session of nitrogen-oxygen inhalation in a randomized, double-blind crossover design

1 day
2 sessions (in-person)

Follow-up

Participants are monitored for changes in depressive symptoms using HDRS and QIDS-C at predefined intervals

1 week
Assessments at 40, 80, 110, and 230 minutes post-administration and 1, 3, and 7 days post-administration

What Are the Treatments Tested in This Trial?

Interventions

  • Nitrogen gas Inhalation Therapy
  • Xenon Inhalation Therapy
Trial Overview The study is testing if inhaling xenon gas helps improve symptoms of depression faster than nitrogen gas when added to usual treatment. It's a double-blind crossover trial where patients try both options randomly without knowing which one they're getting.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: X-TAU (xenon)Active Control1 Intervention
Group II: N-TAU (nitrogen-placebo)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Citations

Xenon Inhalation Therapy for Major Depressive Disorder ...The investigators hypothesize that patients with a primary diagnosis of depression will have a greater decrease in depressive symptoms after one session of ...
Xenon Inhalation Therapy for Major Depressive Disorder ...Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...
Xenon in the treatment of panic disorder: an open label studyXenon is a potentially effective modality in acute treatment of PD; (2) an anti-panic effect of xenon administration persists for at least 6 months.
MGH Study to Explore Effectiveness of Xenon for Major ...Current research indicates that xenon would be well tolerated in patients with MDD and bipolar depression and possibly helpful in alleviating depressive ...
5.rally.massgeneralbrigham.orgrally.massgeneralbrigham.org/study/xenon
Xenon Therapy for Major Depressive Disorder and Bipolar ...We are doing this research study to find out if breathing a xenon-oxygen gas mixture for a short duration helps people with Major Depression or Bipolar ...
Beneficial effects of xenon inhalation on behavioral changes ...Six sessions of 4-min Xe inhalations have shown potency to reduce the severity of panic attacks and the severity of depressive disorders in ...
Xenon - an overview | ScienceDirect TopicsAs of late 2020, no definitive evidence of antidepressant effects in humans has yet been reported.
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