A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
Randomised, double-blind Phase III trial (n=252) comparing flexible-dose intranasal esketamine (56–84 mg, twice weekly for 4 weeks, up to 8 doses) plus a newly initiated oral antidepressant versus oral antidepressant plus intranasal placebo in adults with treatment-resistant depression; primary outcome MADRS change at 28 days.
Details
This randomised, double-blind, parallel-group study evaluated flexible-dose intranasal esketamine administered twice weekly for 4 weeks alongside a newly initiated oral antidepressant compared with oral antidepressant plus intranasal placebo in adults with treatment-resistant depression (MADRS ≥28).
Efficacy was assessed by change from baseline in MADRS total score to end of the 4-week double-blind phase; safety assessments included adverse events, vital signs, ECG and laboratory measures. The trial did not demonstrate significant benefit at 28 days.