NBI-1065845-MDD3025: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety 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

CTIS2024-519420-25-00

Acronym

NBI-1065845-MDD3025

Enrollment

Registered

2025-07-24

Start date

2025-10-22

Completion date

Unknown

Last updated

2026-01-16

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 primary endpoint for this study will be the change from baseline in total MADRS score at Day 56.

Detailed description

Change from baseline in SDS total score at Day 56, Change from baseline in CGI-S score at Day 56

Interventions

DRUGIdentical to NBI-1065845 tablets without active drug

DRUGNBI-1065845

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint for this study will be the change from baseline in total MADRS score at Day 56.	—

Secondary

Measure	Time frame
Change from baseline in SDS total score at Day 56, Change from baseline in CGI-S score at Day 56	—

Countries

Bulgaria, Lithuania, Romania, Slovakia

Outcome results

None listed

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