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

Neurocrine Clinical Site
Oceanside, California 92056

Neurocrine Clinical Site
Orange, California 92868

Neurocrine Clinical Site
San Jose, California 95124

Neurocrine Clinical Site
New Haven, Connecticut 06520

Neurocrine Clinical Site
Miami Gardens, Florida 33014

Neurocrine Clinical Site
Orlando, Florida 32803

Neurocrine Clinical Site
Palm Bay, Florida 32905

Neurocrine Clinical Site
Tampa, Florida 33629

Neurocrine Clinical Site
Iowa City, Iowa 52242

Neurocrine Clinical Site
Marrero, Louisiana 70072

Neurocrine Clinical Site
O'Fallon, Missouri 63368

Neurocrine Clinical Site
Albuquerque, New Mexico 87109

Neurocrine Clinical Site
Glen Oaks, New York 11004

Neurocrine Clinical Site
Charlotte, North Carolina 28211

Neurocrine Clinical Site
Edmond, Oklahoma 73013

Neurocrine Clinical Site
Oklahoma City, Oklahoma 73112

Neurocrine Clinical Site
Philadelphia, Pennsylvania 19104

Neurocrine Clinical Site
Bellaire, Texas 77401

Neurocrine Clinical Site
Stafford, Texas 77477

Neurocrine Clinical Site
Wichita Falls, Texas 76309

Neurocrine Clinical Site
Draper, Utah 84020

Neurocrine Clinical Site
Roanoke, Virginia 24018

More Details

Status
Recruiting
Sponsor
Neurocrine Biosciences

Study Contact

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