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Xenon Inhalation Therapy for Depression

Phase < 1
Recruiting
Led By Andrew Nierenberg, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No serious or active pulmonary disease.
Age greater than or equal to 18 years but less than or equal to 65 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up improvement at day 1
Awards & highlights

Study Summary

This trial is testing whether inhaling xenon gas can help people with treatment-resistant depression. The study is comparing the effects of adding xenon to treatment as usual to adding nitrogen to treatment as usual.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to inhaling xenon or nitrogen-oxygen mixtures as these gases could potentially cause respiratory issues among other risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any serious lung conditions.
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I am between 18 and 65 years old.
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I have no health issues preventing me from receiving treatments with xenon or nitrogen-oxygen mixtures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~improvement at day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and improvement at day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depressive Symptoms

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: X-TAU (xenon)Active Control1 Intervention
Xenon is a potent antiglutaminergic agent that has been used as an anesthetic with minimal side effects, has neuroprotective effects consistent with antidepressants and has the potential to be a novel antidepressant drug. - xenon-oxygen (35:65 ratio by volume) added to treatment as usual (X-TAU group)
Group II: N-TAU (nitrogen-placebo)Placebo Group1 Intervention
Nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group)

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,948 Previous Clinical Trials
13,207,219 Total Patients Enrolled
186 Trials studying Depression
32,349 Patients Enrolled for Depression
Andrew Nierenberg, MDPrincipal InvestigatorMassachussetts General Hospital
2 Previous Clinical Trials
73 Total Patients Enrolled
2 Trials studying Depression
73 Patients Enrolled for Depression

Media Library

Xenon Inhalation Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03748446 — Phase < 1
Depression Research Study Groups: X-TAU (xenon), N-TAU (nitrogen-placebo)
Depression Clinical Trial 2023: Xenon Inhalation Therapy Highlights & Side Effects. Trial Name: NCT03748446 — Phase < 1
Xenon Inhalation Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03748446 — Phase < 1
~1 spots leftby Sep 2024
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