Tests osavampator to help keep depression from returning in adults
Tests osavampator alongside usual treatment in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Key facts
- Where
- Albuquerque, Austin, Bellaire, Charlotte, Draper, Edmond, Friendswood, Glen Oaks, Iowa City, Marrero, Miami Gardens, New Haven, O'Fallon, Oceanside, Oklahoma City, Orange, Orlando, Palm Bay, Philadelphia, Roanoke, San Jose, Stafford, Tampa, and Wichita Falls, United StatesSee the 24 sites
- Phase
- Phase 3
Where in United States
- AlbuquerqueAlbuquerque, United StatesNo longer taking part
- AustinAustin, United StatesNo longer taking part
- BellaireBellaire, United StatesTaking people
- CharlotteCharlotte, United StatesTaking people
- DraperDraper, United StatesTaking people
- EdmondEdmond, United StatesTaking people
- FriendswoodFriendswood, United StatesNo longer taking part
- Glen OaksGlen Oaks, United StatesTaking people
- Iowa CityIowa City, United StatesTaking people
- MarreroMarrero, United StatesTaking people
- Miami GardensMiami Gardens, United StatesTaking people
- New HavenNew Haven, United StatesTaking people
- O'FallonO'Fallon, United StatesTaking people
- OceansideOceanside, United StatesTaking people
- Oklahoma CityOklahoma City, United StatesTaking people
- OrangeOrange, United StatesTaking people
- OrlandoOrlando, United StatesTaking people
- Palm BayPalm Bay, United StatesTaking people
- PhiladelphiaPhiladelphia, United StatesTaking people
- RoanokeRoanoke, United StatesTaking people
- San JoseSan Jose, United StatesTaking people
- StaffordStafford, United StatesTaking people
- TampaTampa, United StatesTaking people
- Wichita FallsWichita Falls, 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
- NCT07196501EU 2025-520541-72-00
- Record updated
- 22 October 2026
- Original description
The primary objective of this study is to evaluate the efficacy of osavampator (previously NBI-1065845) compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
The primary objective of this study is to evaluate the efficacy of osavampator (previously NBI-1065845) compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) 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 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; Note: Other protocol-defined Inclusion and Exclusion criteria may apply; Are considered by the investigator to be at imminent risk of suicide or injury to self or others.