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
- Avon Lake, Boston, Dallas, Everett, Garden Grove, Hollywood, Houston, Little Rock, Maitland, Mount Kisco, Orange, Pico Rivera, Richmond, San Diego, The Woodlands, Upland, Watertown, and Westlake, United StatesSee the 18 sites
- Phase
- Phase 3
Where in United States
- Avon LakeAvon Lake, United StatesTaking people
- BostonBoston, United StatesTaking people
- DallasDallas, United StatesTaking people
- EverettEverett, United StatesTaking people
- Garden GroveGarden Grove, United StatesNo longer taking part
- HollywoodHollywood, United StatesTaking people
- HoustonHouston, United StatesTaking people
- Little RockLittle Rock, United StatesTaking people
- MaitlandMaitland, United StatesTaking people
- Mount KiscoMount Kisco, United StatesTaking people
- OrangeOrange, United StatesTaking people
- Pico RiveraPico Rivera, United StatesTaking people
- RichmondRichmond, United StatesNo longer taking part
- San DiegoSan Diego, United StatesTaking people
- The WoodlandsThe Woodlands, United StatesNo longer taking part
- UplandUpland, United StatesTaking people
- WatertownWatertown, United StatesNo longer taking part
- WestlakeWestlake, United StatesNo longer taking part
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.