Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03748446
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Xenon — DRUG
    The investigators have chosen to use as a maximum concentration about half the general anesthetic partial pressure of xenon (35%=70%/2) to achieve a dose that is sub-anesthetic. This concentration of xenon is very close to that at which subjects emerging from xenon anesthesia first respond to verbal commands, commonly referred to as MAC awake.
  • Nitrogen gas — DRUG
    nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual

Study Details

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.

Key Dates

Start date
Dec 5, 2019
Status verified
May 2025
Primary completion
Sep 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: X-TAU (xenon)
    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)
  • Placebo Comparator: N-TAU (nitrogen-placebo)
    Nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group)

Primary Outcome Measure

Depressive Symptoms [ Time Frame: Improvement at day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dauten Family Center for Bipolar Treatment InnovationBostonMassachusetts02114
Andrew Nierenberg, MD

Find similar trials in Boston, MA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Dauten Family Center for Bipolar Treatment Innovation· Boston, MA

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