A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
← catalyst calendarNCT07196501 · readout ≤ 712 d
Sponsored by Neurocrine Biosciences (industry) · NBIX — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
550estimated
Sites
60
Countries
Australia, Bulgaria, Canada +8
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 | 2025-08-18 | actual | When the study began enrolling |
| Primary completion | Jul 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-29 | 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
Interventions
- Drug: NBI-1065845
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFTime from Randomization to Relapse
measured From randomization to the earliest of relapse or end-of study (up to approximately 32 months)
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