Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06786624

Enrollment

200

Registered

2025-01-22

Start date

2025-01-22

Completion date

2027-07-31

Last updated

2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

MDD, Depression, Major Depressive Disorder, NBI-1065845, TAK-653, MADRS

Brief summary

The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.

Interventions

DRUGNBI-1065845

NBI-1065845 tablets

DRUGPlacebo

Matching placebo tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder. * Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression. * Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study. * Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1). * Willing and able to comply with all study procedures and restrictions in the opinion of the investigator. Key

Exclusion criteria

* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD. * Are considered by the investigator to be at imminent risk of suicide or injury to self or others. * Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56	Baseline, Day 56

Secondary

Measure	Time frame
Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56	Baseline, Day 56
Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56	Baseline, Day 56

Countries

United States

Contacts

Primary ContactNeurocrine Medical Information Call Center

medinfo@neurocrine.com1-877-641-3461

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026