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
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 moderate or severe recurrent major depression, or persistent depressive disorder, who did not respond well enough to 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, with a HAM-D17 score of 22 or higher at screening and at Day 1
- Earlier treatment
- Must have taken oral antidepressants for at least 8 weeks with an inadequate response in the current episode, and be willing to keep the same antidepressants at the same dose throughout the study
Main reasons for not taking part
- Another psychiatric disorder diagnosed in the last 1 year that was the main focus of treatment
- Judged by the investigator to be at imminent risk of suicide or injury to self or others
- Depression that did not respond to electroconvulsive therapy (ECT) in the current episode
Read by machine on 9 November 2026.
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.