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

Name: Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) — clinical trial record (NCT06966401)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorNeurocrine Biosciences

Started2025-04-16

View on ClinicalTrials.gov ↗

Amendment history

2026-07-22

Study Status, Contacts/Locations v4

Trial sites expanded: 98 → 106 locations

2026-06-18

Study Status, Contacts/Locations v3

Trial sites expanded: 87 → 98 locations

2026-04-20

Study Status, Study Design, Contacts/Locations v2

Enrollment target600→850

Study sites18→87

2025-07-29

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

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-05→confirmed 2025-04-16

Study sites0→18

2025-05-07

Original filing

Neurocrine Biosciences

25 trials monitored

See 1 trial at risk

Depression

2,976 trials monitored

See 162 trials at risk

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

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