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
- Atlanta, Avon Lake, Bellaire, Boston, Bryant, Cedarhurst, Chino, Cromwell, Dallas, DeSoto, Draper, Edmond, Farmington, Gaithersburg, Glendale, Hollywood, Houston, Huntsville, Irvine, Little Rock, Los Angeles, Maitland, Miami, Miami Gardens, Mount Kisco, New York, O'Fallon, Oceanside, Oklahoma City, Orange, Orlando, Palm Bay, Philadelphia, Pico Rivera, Richmond, Saint Charles, San Diego, San Francisco, San Jose, Stafford, Tampa, The Bronx, The Woodlands, Upland, and Watertown, United StatesSee the 45 sites
- Phase
- Phase 3
Where in United States
- AtlantaAtlanta, United StatesTaking people
- Avon LakeAvon Lake, United StatesTaking people
- BellaireBellaire, United StatesNo longer taking part
- BostonBoston, United StatesTaking people
- BryantBryant, United StatesTaking people
- CedarhurstCedarhurst, United StatesTaking people
- ChinoChino, United StatesTaking people
- CromwellCromwell, United StatesTaking people
- DallasDallas, United StatesTaking people
- DeSotoDeSoto, United StatesTaking people
- DraperDraper, United StatesTaking people
- EdmondEdmond, United StatesTaking people
- FarmingtonFarmington, United StatesTaking people
- GaithersburgGaithersburg, United StatesTaking people
- GlendaleGlendale, United StatesTaking people
- HollywoodHollywood, United StatesTaking people
- HoustonHouston, United StatesTaking people
- HuntsvilleHuntsville, United StatesTaking people
- IrvineIrvine, United StatesTaking people
- Little RockLittle Rock, United StatesTaking people
- Los AngelesLos Angeles, United StatesTaking people
- MaitlandMaitland, United StatesTaking people
- MiamiMiami, United StatesTaking people
- Miami GardensMiami Gardens, United StatesTaking people
- Mount KiscoMount Kisco, United StatesTaking people
- New YorkNew York, United StatesTaking people
- O'FallonO'Fallon, United StatesTaking people
- OceansideOceanside, United StatesTaking people
- Oklahoma CityOklahoma City, United StatesNo longer taking part
- OrangeOrange, United StatesTaking people
- OrlandoOrlando, United StatesNo longer taking part
- Palm BayPalm Bay, United StatesTaking people
- PhiladelphiaPhiladelphia, United StatesTaking people
- Pico RiveraPico Rivera, United StatesTaking people
- RichmondRichmond, United StatesNo longer taking part
- Saint CharlesSaint Charles, United StatesTaking people
- San DiegoSan Diego, United StatesTaking people
- San FranciscoSan Francisco, United StatesNo longer taking part
- San JoseSan Jose, United StatesTaking people
- StaffordStafford, United StatesTaking people
- TampaTampa, United StatesTaking people
- The BronxThe Bronx, United StatesTaking people
- The WoodlandsThe Woodlands, United StatesTaking people
- UplandUpland, United StatesNo longer taking part
- WatertownWatertown, United StatesTaking 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.