NBI-1065845-MDD3028: A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519423-24-00

Acronym

NBI-1065845-MDD3028

Enrollment

261

Registered

2025-07-01

Start date

2025-10-07

Completion date

Unknown

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Brief summary

The occurrence of adverse events (AEs) up to Week 52.

Interventions

DRUGNBI-1065845

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The occurrence of adverse events (AEs) up to Week 52.	—

Countries

Belgium, Bulgaria, Croatia, Czechia, Finland, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Romania, Slovakia, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026