Phase 3 Study to Test NBI-1065845 Compared to Placebo for Treating Major Depressive Disorder

What this Trial Is About

Researchers are evaluating the efficacy of NBI-1065845 compared with a placebo as an additional treatment in adults with Major Depressive Disorder MDD. The study focuses on participants who have moderate to severe depression or persistent depressive disorder and who have not adequately responded to oral antidepressant treatments. This Phase 3, randomized, double-blind, placebo-controlled trial aims to assess how well NBI-1065845 improves symptoms of depression over the course of treatment. Participants will receive either NBI-1065845 tablets or matching placebo tablets, both administered orally once a day. The study treatment is given alongside participants ongoing oral antidepressant therapy, which they must continue at the same dose and frequency throughout the trial. The treatment period lasts for 56 days, during which participants are monitored closely. During the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS to measure changes in depression symptoms, as well as evaluations using the Sheehan Disability Scale SDS and Clinical Global Impression-Severity Scale CGI-S at baseline and day 56. The trial includes safety monitoring and adherence to study procedures, with a total participation duration of at least 56 days.

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