A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Study Status: Recruiting

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Sex: ALL
Minimum Age: 18 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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.

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Conditions

Major Depressive Disorder

Intervention/Treatment

DRUG : NBI-1065845
DRUG : Placebo

Sponsor

Neurocrine Biosciences

Principal Investigator(s)

Clinical Development Lead, STUDY_DIRECTOR, Neurocrine Biosciences

Phase

PHASE3