Long-term safety study of NBI-1065845 added to treatment for depression
Tests NBI-1065845 as an added treatment in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Key facts
- Where
- Grad Zagreb, CroatiaSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with recurrent moderate or severe major depression, or persistent depressive disorder, whose depression has not improved enough on oral antidepressants.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Recurrent major depressive disorder (moderate or severe) or persistent depressive disorder
- Earlier treatment
- Inadequate response to oral antidepressants in the current episode; must have taken oral antidepressants for at least 8 weeks before screening
Main reasons for not taking part
- Another psychiatric disorder in the last 1 year that was the main focus of treatment
- Considered by the investigator to be at imminent risk of suicide or injury to self or others
Read by machine on 9 November 2026.
Where in Croatia
- Clinic for psychiatry Sveti IvanGrad Zagreb, CroatiaTaking people
- KBC ZagrebGrad Zagreb, CroatiaTaking people
- Klinika za psihijatriju VrapceGrad Zagreb, CroatiaTaking people
- Poliklinika Solmed d.o.o.Grad Zagreb, CroatiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Neurocrine Biosciences
- Trial code
- NCT06966401EU 2024-519423-24-00
- Record updated
- 2 November 2026
- Original description
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.Read full original descriptionShow less
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)
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Inclusion: Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder; Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression; Participant must have been taking oral antidepressants for at least 8 weeks prior to screening; Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
Exclusion: A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD; Are considered by the investigator to be at imminent risk of suicide or injury to self or others; Other protocol defined inclusion and exclusion criteria apply.