Study of NBI-1065845 Compared to Placebo as Additional Treatment for Adults With Major Depressive Disorder

What this Trial Is About

Researchers are evaluating the effectiveness of NBI-1065845 compared with a placebo as an additional treatment to improve symptoms in adults with major depressive disorder MDD. The study focuses on participants who have recurrent moderate to severe MDD or persistent depressive disorder and who have not responded adequately to oral antidepressants in their current episode. This Phase 3 trial is designed to assess both the efficacy and safety of this investigational drug. Participants will be randomly assigned to receive either NBI-1065845 or a matching placebo, both administered orally once a day. The study is double-blind, meaning neither participants nor researchers know which treatment is given. Treatment duration lasts 56 days, during which participants continue their current oral antidepressant medication at the same dose. The study uses a parallel design with two groups receiving either the drug or placebo. During the trial, participants will be assessed at baseline and at Day 56 using several scales to measure changes in depression severity and disability. These include the Montgomery-5sberg Depression Rating Scale MADRS, the Sheehan Disability Scale SDS, and the Clinical Global Impression-Severity Scale CGI-S. Participants must comply with all study procedures and restrictions, and their safety and response to treatment will be closely monitored throughout the study period, which ends in July 2027.

NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)