Orlova 4

Researchers are evaluating the efficacy and safety of milsaperidone as an additional treatment for patients with Major Depressive Disorder MDD who have not responded adequately to antidepressant therapy. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare milsaperidone with a placebo to better understand its potential benefits and risks in this population. The study involves two groups one receiving oral milsaperidone and the other receiving an oral placebo. Participants will be randomly assigned to one of these groups, and neither they nor the researchers will know which treatment is given during the study. This design helps ensure unbiased results about how milsaperidone performs as an add-on therapy compared to placebo. Participants will be involved in the study for at least six weeks, during which their depression symptoms will be assessed using the Montgomery-Asberg Depression Rating Scale MADRS to measure changes from baseline. The study will monitor safety and effectiveness closely throughout this period. The trial is sponsored by Vanda Pharmaceuticals and is expected to run until March 2028.