Xenon Inhalation Therapy for Depression

Overseen By Andrew Nierenberg, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Massachusetts General Hospital

Must be taking: Antidepressants, Mood stabilizers

Must not be taking: Benzodiazepines

Disqualifiers: Psychosis, Schizophrenia, OCD, others

Compensation: Varies

Number of Visits: 42

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Andrew Nierenberg, MD

Principal Investigator

Massachussetts General Hospital

Eligibility Criteria

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.

Exclusion Criteria

I am currently taking a benzodiazepine medication.

Unwilling or unable to comply with study procedures.

I do not have any uncontrolled serious health conditions.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: X-TAU (xenon) Active Control 1 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 Group 1 Intervention

Nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group)

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+