drugset / Trial / NCT07196501

A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT07196501

Phase 3 Recruiting 550 enrolled Neurocrine Biosciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Timeline

Start
2025-08-18
Primary completion
2028-07
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject OSAVAMPATOR Small molecule Oral