Clinical TrialNitrous OxidePlaceboCompleted

Effects of Nitrous Oxide Augmentation of the Selective Serotonin Reuptake Inhibitors Treatment of Major Depressive Disorder

Double-blind randomized parallel-group trial of adjunctive nitrous oxide (50% N2O/50% O2, 60 min twice weekly for 4 weeks; n=12) vs placebo (100% O2, same schedule; n=11) added to stable SSRI treatment in MDD patients aged 18–65 with HDRS-17 > 17. Primary outcome: HDRS-17 change from baseline. Sponsor: Hospital das Clínicas FMRP-USP, Ribeirão Preto, Brazil.

Ask Blossom about this trial
Target Enrollment
23 participants
Study Type
Phase I/II interventional
Design
Randomized, double Blind

Study Arms & Interventions

N2O

experimental

50% nitrous oxide diluted in 50% oxygen inhaled for 60 minutes twice a week for 4 weeks

Interventions

  • Nitrous Oxide50 %
    via Inhalation• twice weekly• 8 doses total

    50% N2O diluted in 50% oxygen; administered via disposable nasal mask

Placebo

placebo

100% oxygen inhaled for 60 minutes twice a week for 4 weeks

Interventions

  • Placebo100 %
    via inhaled• twice weekly• 8 doses total

    100% oxygen used as placebo

Study Details

  • Status
    Completed
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment23 participants
  • Timeline
    Start: 2016-06-10
  • Compounds
    Nitrous OxidePlacebo

Related Publications

Open AccessindividualPrimary

Nitrous oxide as an adjunctive therapy in major depressive disorder: a randomized controlled double-blind pilot trial

This double-blind placebo-controlled between-subjects study (n=23) tested the antidepressant efficacy of inhaled nitrous oxide (50% N2O|50% O2 versus 100% O2) in patients diagnosed with major depression (MDD). Across multiple treatment sessions administered across a period of 4 weeks, there were significant reductions in depressive symptoms in the acute response to treatment and accumulatively across sessions.

Published
Journal
brazilian Journal of Psychiatry
Authors
Guimarães, M. C., Guimarães, T. M., Hallak, J. E., Abrão, J., Machado-de-Sousa, J. P.