A randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single subcutaneous MIJ821 injection in addition to standard of care in participants with treatment-resistant depression
Randomised, double-blind, placebo-controlled, parallel-group Phase II trial (n=56) testing a single subcutaneous MIJ821 injection plus standard care versus placebo in participants with treatment-resistant depression (TRD).
Details
This Phase II, multicentre, double-blind, randomised, placebo-controlled trial evaluates efficacy, safety, tolerability and pharmacokinetics of a single subcutaneous injection of MIJ821 added to standard of care in adults with treatment-resistant depression.
Primary endpoint is change in MADRS total score at 24 hours post dose versus baseline; secondary endpoints include safety/TEMs, CADSS, MOAA/S, C-SSRS, PK parameters (AUC, Cmax, Tmax), and MADRS at Days 8, 15, 22 and 29.
Sponsor: Novartis Farmacéutica, S.A. (protocol CMIJ821B12201). Planned multinational sites include Spain, Japan, United States, Poland and Czechia; total planned enrollment ~56 participants.