Clinical TrialCrossoverNitrous OxidePlaceboCompleted

Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies

The purpose of the study aims to determine whether different concentrations of nitrous oxide (N2O) have different antidepressant effects for adults with treatment-resistant major depression.

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Target Enrollment
Not specified
Study Type
Phase II interventional
Design
Randomized

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Related paper: A phase 2 trial of inhaled nitrous oxide for treatment-resistant major depressionCompound research: Nitrous Oxide

Study Arms & Interventions

Nitrous Oxide 50%

experimental

Single 1-hour inhalation of 50% nitrous oxide in oxygen

Interventions

  • Nitrous Oxide50 %
    via Inhalation• single dose• 1 doses total

    balanced with air/oxygen

Nitrous Oxide 25%

experimental

Single 1-hour inhalation of 25% nitrous oxide in oxygen

Interventions

  • Nitrous Oxide25 %
    via Inhalation• single dose• 1 doses total

    balanced with air/oxygen

Placebo (matched to nitrous oxide)

placebo

Single 1-hour inhalation of placebo (air/oxygen)

Interventions

  • Placebo0 %
    via inhaled• single dose• 1 doses total

    air/oxygen

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomized
  • Timeline
    Start: 2016-11-22
    End: 2020-02-18
  • Compounds
    Nitrous OxidePlacebo

Study Team

Sponsors & Collaborators

Investigators

  • BP
    Ben Julian Palanca

Related Publications

PaywallindividualPrimary

A phase 2 trial of inhaled nitrous oxide for treatment-resistant major depression

In a phase 2 trial, inhaled nitrous oxide at 25% concentration improved symptoms of treatment‑resistant major depression and produced fewer adverse effects than the 50% concentration.

Published
Journal
Science Translational Medicine
Authors
Nagele, P., Palanca, B. J., Gott, B., Brown, F., Barnes, L., Nguyen, T., Xiong, W., Salloum, N. C., Espejo, G. D., Lessov-Schlaggar, C. N., Jain, N., Cheng, W. W. L., Komen, H., Yee, B., Bolzenius, J. D., Janski, A., Gibbons, R., Zorumski, C. F., Conway, C. R.

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