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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.

Must not have

Currently taking a benzodiazepine (including PRN).

Any unstable medical illness (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up improvement at day 1

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking a benzodiazepine medication.

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I do not have any uncontrolled serious health conditions.

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I can follow the study's schedule and procedures.

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I have not taken any experimental mental health drugs in the past 6 months.

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I have had a brain injury or a condition with trapped air that could expand inside my body.

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I have been diagnosed with a mental health condition such as MDD, bipolar disorder with psychosis, schizophrenia, OCD, or an anxiety disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ improvement at day 1

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

0 / 9Eligibility criteria met