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NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Name: NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) — clinical trial record (NCT06963021)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorNeurocrine Biosciences

Started2025-05-30

View on ClinicalTrials.gov ↗

Amendment history

2026-08-07

Study Status, Contacts/Locations v6

Study sites34→35

2026-06-22

Study Status, Contacts/Locations v5

Trial sites expanded: 30 → 34 locations

2026-04-10

Study Status, Contacts/Locations v4

Study sites16→30

2025-12-18

Study Status, Contacts/Locations v3

Study sites9→16

2025-09-04

Study Status, Contacts/Locations v2

Study sites5→9

2025-06-25

Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-05→confirmed 2025-05-30

Study sites0→5

2025-04-30

Original filing

Neurocrine Biosciences

25 trials monitored

See 1 trial at risk

Depression

2,976 trials monitored

See 162 trials at risk

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	NCT06963021
Lead Sponsor	Neurocrine Biosciences
Conditions	Major Depressive Disorder
Enrollment	200 participants
Start Date	2025-05-30
Primary Completion	2027-07 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2026-08-10