Trials Today

NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

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

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.

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

Arm	Description	Assigned 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 5368361, California 5332921 90025

Neurocrine Clinical Site
Aurora 5412347, Colorado 5417618 80045

Neurocrine Clinical Site
Cromwell 4832121, Connecticut 4831725 06416

Neurocrine Clinical Site
Farmington 4834272, Connecticut 4831725 06030

Neurocrine Clinical Site
Maitland 4163220, Florida 4155751 32751

Neurocrine Clinical Site
Tampa 4174757, Florida 4155751 33613

Neurocrine Clinical Site
Gaithersburg 4355843, Maryland 4361885 20877

Neurocrine Clinical Site
Cedarhurst 5111974, New York 5128638 11516

Neurocrine Clinical Site
New York 5128581, New York 5128638 10029

Neurocrine Clincial Site
New York 5128581, New York 5128638 10128

More Details

NCT ID: NCT06963021
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.