A Phase 3 interventional study of NBI-1065845 in Major Depressive Disorder, sponsored by Neurocrine Biosciences. Recruiting at 120 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Neurocrine Biosciences · Phase 3, Interventional, and Treatment
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment 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 850 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:
Other protocol defined inclusion and exclusion criteria apply.
NBI-1065845 administered orally once a day.
Drug: NBI-1065845
NBI-1065845 tablets
Also known as: TAK-653
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline through Week 52
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Showing the first 100 of 120 sites across 23 countries. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for May 2029, 49 months after the start.
Of 95 industry-sponsored phase 3 interventional studies under Depressive Disorder, Major, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 33. This study's planned 49 months is above that.
Counting every sponsor, half of 124 studies reached it within 27 months; a quarter within 21 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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