Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Protocol Amendment History 2 changes
notable Trial sites expanded: 98 -> 106 locations 2026-07-25
notable Trial sites expanded: 87 -> 98 locations 2026-06-23
Trial Details
NCT Number NCT06966401
Lead Sponsor Neurocrine Biosciences
Conditions Major Depressive Disorder
Enrollment 850 participants
Start Date 2025-04-16
Primary Completion 2029-05 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-24