NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

• NBI-1065845 (Drug), also known as TAK-653: NBI-1065845 tablets
• Placebo (Drug): Matching placebo tablets

Primary outcomes

• Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56 [Baseline, Day 56]

Secondary outcomes

• 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]

Sex: All, ages: 18 Years to any

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.

• Clinical Development Lead, Study director, Neurocrine Biosciences