A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Key facts
- Where
- Calgary, Kingston, North Vancouver, Sherbrooke, and Toronto, CanadaSee the 5 sites
- Phase
- Phase 3
Where in Canada
- CalgaryCalgary, CanadaTaking people
- KingstonKingston, CanadaTaking people
- North VancouverNorth Vancouver, CanadaTaking people
- SherbrookeSherbrooke, CanadaNo longer taking part
- TorontoToronto, CanadaTaking 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
- 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.