Nitrous oxide (N2O) and subsequent open-label SSRI treatment of adolescents with depression (NOTAD): study protocol for a randomised controlled trial.
Trials December 22, 2017 Richard M Stewart, Janice W Y Wong, Kevin C Runions et al.
A single-blind, randomized, placebo-controlled trial will test whether a single one-hour inhalation of nitrous oxide (N2O) produces antidepressant effects in adolescents aged 12–17 with major depressive disorder. The study has two phases: in phase A, participants receive either N2O or placebo (air); in phase B, all receive open-label fluoxetine for 12 weeks. Mood will be assessed at 2 and 24 hours after inhalation and weekly during follow-up. The authors expect N2O to show antidepressant effects at 24 hours and, when combined with subsequent SSRI treatment, to produce greater improvement than placebo plus SSRI alone, potentially reducing the typical delay in symptom relief from SSRIs.