Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
← catalyst calendarNCT06786624 · readout ≤ 346 d
Sponsored by Neurocrine Biosciences (industry) · NBIX — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
200estimated
Sites
18
Country
United States
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 | 2025-01-22 | actual | When the study began enrolling |
| Primary completion | Jul 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-29 | 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 — also filed as TAK-653
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
measured Baseline, Day 56
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