Tests NBI-1065845 added to usual treatment for major depression
Tests NBI-1065845 alongside usual treatment in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Key facts
- Where
- Bucharest, Craiova, and Oradea, RomaniaSee the 4 sites
- Phase
- Phase 3
Where in Romania
- Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. StelianBucharest, RomaniaTaking people
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru ObregiaBucharest, RomaniaTaking people
- Institutul Privat de Cercetari Melchisedec, pentru Boli Autoimune, Ereditare si Rare - IPCMCraiova, RomaniaTaking people
- Spitalul Clinic Judetean De Urgenta BihorOradea, RomaniaTaking 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
- NCT06911112EU 2024-519420-25-00
- Record updated
- 11 August 2026
- 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.