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
- Belchatow, Bia?ystok, Białystok, Bydgoszcz, Gdansk, Grudziądz, Katowice, Torun, and Warsaw, PolandSee the 12 sites
- Phase
- Phase 3
Where in Poland
- Gabinet Lekarski Psychiatryczny Ireneusz KaczorowskiBelchatow, PolandTaking people
- Podlaskie Centrum PsychogeriatriiBia?ystok, PolandTaking people
- MłynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna ŁazarczykBiałystok, PolandTaking people
- Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka TomczakBiałystok, PolandTaking people
- Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata TrzaskaBydgoszcz, PolandTaking people
- Centrum Badan Klinicznych PI-House sp. z o.o.Gdansk, PolandTaking people
- Centrum Zdrowia AlceaGdansk, PolandTaking people
- Przychodnie Grudziadz sp. z o.o.Grudziądz, PolandTaking people
- Care Clinic Sp. Z O.O.Katowice, PolandTaking people
- Clinic BBP Bożena PawełczykKatowice, PolandTaking people
- Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak Malgorzata TrzaskaTorun, PolandTaking people
- Gyncentrum Sp. z o. o.Warsaw, PolandTaking 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?
Trial 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.