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

Purpose

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.

Condition

  • Major Depressive Disorder

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The study consists of a non-randomized open-label treatment period and a randomized double-blind maintenance period.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Open-label Treatment Period: NBI-1065845
Participants will be treated with NBI-1065845 during the open-label treatment period.
  • Drug: NBI-1065845
    Oral tablet
Experimental
Randomized Double-blind Maintenance Period: NBI-1065845
Participants will be randomized to receive NBI-1065845 during the randomized double-blind maintenance period.
  • Drug: NBI-1065845
    Oral tablet
Experimental
Randomized Double-blind Maintenance Period: Placebo
Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period.
  • Drug: Placebo
    Oral tablet

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Neurocrine Biosciences

Study Contact

Neurocrine Medical Information Call Center
1-877-641-3461
medinfo@neurocrine.com