Xenon Inhalation Therapy for Depression

Recruiting in Palo Alto (17 mi)

Overseen ByAndrew Nierenberg, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Massachusetts General Hospital

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.

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

I do not have any serious lung conditions.

I am between 18 and 65 years old.

I have no health issues preventing me from receiving treatments with xenon or nitrogen-oxygen mixtures.

Exclusion Criteria

I am currently taking a benzodiazepine medication.

I do not have any uncontrolled serious health conditions.

I can follow the study's schedule and procedures.

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

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

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

Participant Groups

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.

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)