A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression (TRANSFORM-3)
Randomized, double-blind, active-controlled Phase III study (n=139) in elderly participants with TRD testing intranasal esketamine (flexible 28–84 mg, twice weekly for 4 weeks) plus a new oral antidepressant versus intranasal placebo plus a new oral antidepressant.
Details
This multicentre, randomized, double-blind, active-controlled trial evaluated efficacy, safety, and tolerability of flexible-dose intranasal esketamine administered twice weekly for 4 weeks in elderly participants (>=65 years) with treatment-resistant depression, each initiating a new oral antidepressant.
Participants started Day 1 with 28 mg intranasal esketamine; Day 4 dose was 28 or 56 mg and subsequent doses could be 28, 56 or 84 mg per investigator judgement. Oral antidepressant options (duloxetine, escitalopram, sertraline, venlafaxine XR) were started on Day 1 and continued through the double-blind induction phase.
Primary efficacy was change in MADRS total score at Week 4; safety monitoring included vital signs, labs, and protocol-specified cardiac and cognitive assessments.