Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
← catalyst calendarNCT06966401 · readout ≤ 1,016 d
Sponsored by Neurocrine Biosciences (industry) · NBIX — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
850estimated
Sites
106
Countries
Belgium, Bulgaria, Canada +17
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-04-16 | actual | When the study began enrolling |
| Primary completion | May 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Major Depressive Disorder
Intervention
- Drug: NBI-1065845 — also filed as TAK-653
Primary outcome
what the primary-completion date above is the date OFNumber of Participants with Treatment-emergent Adverse Events (TEAEs)
measured Baseline through Week 52
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