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Purpose

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.

Condition

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.

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)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NBI-1065845 		NBI-1065845 administered orally once a day.
  • Drug: NBI-1065845
    NBI-1065845 tablets
    Other names:
    • TAK-653
Placebo Comparator
Placebo 		Placebo identical in appearance to NBI-1065845 will be administered orally once a day.
  • Drug: Placebo
    Matching placebo tablets

Recruiting Locations

Neurocrine Clinical Site
Los Angeles, California 90025

Neurocrine Clinical Site
Aurora, Colorado 80045

Neurocrine Clinical Site
Cromwell, Connecticut 06416

Neurocrine Clinical Site
Farmington, Connecticut 06030

Neurocrine Clinical Site
Maitland, Florida 32751

Neurocrine Clinical Site
Tampa, Florida 33613

Neurocrine Clinical Site
Gaithersburg, Maryland 20877

Neurocrine Clinical Site
Cedarhurst, New York 11516

Neurocrine Clinical Site
New York, New York 10029

Neurocrine Clincial Site
New York, New York 10128

More Details

Status
Recruiting
Sponsor
Neurocrine Biosciences

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.