A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression (TRANSFORM-2)
The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) subjects from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.
Details
Randomized, double-blind, active-controlled, multicentre Phase III study in adults with treatment-resistant major depressive disorder comparing flexible-dose intranasal esketamine plus a new oral antidepressant versus intranasal placebo plus a new oral antidepressant.
Double-blind induction phase: 4 weeks with intranasal dosing twice weekly (start 56 mg, may increase to 84 mg per protocol) and initiation of one of four open-label oral antidepressants; safety and efficacy assessed acutely and during a 24-week follow-up for non-rollover participants.
Primary outcomes assess antidepressant efficacy in TRD; safety monitoring includes adverse events, vital signs, and tolerability with specified dose adjustments for tolerability through Day 15.