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

StatusRecruiting
PhasePhase 3
Started2025-03-31
View on ClinicalTrials.gov ↗

Amendment history

2026-08-07
minor
Study Status, Contacts/Locations v3
Trial sites expanded: 10 → 39 locations
2025-11-26
minor
Study Status, Contacts/Locations v2
Study sites1→10
2025-04-30
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-04→confirmed 2025-03-31
Study sites0→1
2025-03-28
minor
Original filing
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
Trial Details
NCT Number NCT06911112
Lead Sponsor Neurocrine Biosciences
Conditions Major Depressive Disorder
Enrollment 200 participants
Start Date 2025-03-31
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-11