Tests NBI-1065845 added to usual treatment for major depressive disorder
Compares NBI-1065845 with placebo, added to current treatment, in adults with depression.
Plain-language title generated from the registry record
Registry title: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Key facts
- Where
- Belchatow, Bia?ystok, Białystok, Gdansk, Grudziądz, Katowice, and Torun, PolandSee the 8 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
- Centrum Badan Klinicznych PI-House sp. z o.o.Gdansk, 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
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
- NCT06786624EU 2024-519418-29-00
- Record updated
- 29 October 2025
- Original description
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.Read full original descriptionShow less
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)
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
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 and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study; Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1); 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; Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode; Are considered by the investigator to be at imminent risk of suicide or injury to self or others.