A Phase 3 interventional study of Osavampator and Placebo in Major Depressive Disorder, sponsored by Neurocrine Biosciences. Recruiting at 61 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Neurocrine Biosciences · Phase 3, Interventional, and Treatment
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 550 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Neurocrine Biosciences is the lead sponsor of 86 studies on the registry; 16 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Participants will be treated with osavampator during the open-label treatment period.
Drug: Osavampator
Participants will be randomized to receive osavampator during the randomized double-blind maintenance period.
Drug: Osavampator
Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period.
Drug: Placebo
Oral tablet
Also known as: NBI-1065845
Oral tablet
Time from Randomization to Relapse
Time frame: From randomization to the earliest of relapse or end-of study (up to approximately 32 months)
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Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Osavampator