A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression (TRANSFORM-1)
Randomized, double-blind, active-controlled Phase III study (n=346) comparing fixed-dose intranasal esketamine (56 mg or 84 mg) plus a newly initiated oral antidepressant versus intranasal placebo plus a newly initiated oral antidepressant in adults with treatment-resistant depression.
Details
This multicenter, randomized, double-blind, active-controlled study enrolled adults with treatment-resistant major depressive disorder to assess efficacy and safety of fixed doses of intranasal esketamine (56 mg or 84 mg) administered twice weekly plus a newly initiated oral antidepressant versus matching intranasal placebo plus a newly initiated oral antidepressant.
The trial included a screening/prospective observational phase (4–7 weeks), a 4-week double-blind induction phase (twice-weekly dosing), and a 24-week follow-up; primary outcome was change in MADRS total score at Week 4. Safety monitoring included adverse events, vital signs, and assessments per protocol.