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

Name: A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) — clinical trial record (NCT07196501)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorNeurocrine Biosciences

Started2025-08-18

View on ClinicalTrials.gov ↗

Amendment history

2026-07-22

Study Status, Contacts/Locations v3

Trial sites expanded: 45 → 60 locations

2026-03-17

Study Status, Contacts/Locations v2

Study sites31→45

2026-01-12

Study Identification, Study Status, Contacts/Locations v1

Study sites4→31

2025-09-19

Original filing

Neurocrine Biosciences

25 trials monitored

See 1 trial at risk

Depression

2,976 trials monitored

See 162 trials at risk

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.

Trial Details

NCT Number	NCT07196501
Lead Sponsor	Neurocrine Biosciences
Conditions	Major Depressive Disorder
Enrollment	550 participants
Start Date	2025-08-18
Primary Completion	2028-07 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-07-24