A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
Phase IV, double-blind, randomised, parallel-group trial (n=477) comparing esketamine nasal spray 56 mg and 84 mg versus placebo twice weekly for 4 weeks in adults with treatment-resistant depression, primary outcome change in MADRS from baseline to Day 28.
Details
Randomised, double-blind, parallel-group study evaluating efficacy of esketamine nasal spray 56 mg and 84 mg versus placebo in adults with treatment-resistant depression over a 4-week double-blind phase; primary endpoint is change in MADRS total score from baseline to Day 28.
Dosing consisted of intranasal self-administration twice weekly for 4 weeks (8 dosing sessions); study also included screening, safety assessments (vitals, ECG, labs), and option to enter an open-label treatment/observation phase after Day 28.