RECRUITING

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

Description

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.

Conditions

Major Depressive Disorder
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Related Conditions:

Major Depressive Disorder

Study Overview

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Study Details

Study overview

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.

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

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

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Orange

Neurocrine Clinical Site, Orange, California, United States, 92866

Maitland

Neurocrine Clinical Site, Maitland, Florida, United States, 32751

Boston

Neurocrine Clinical Site, Boston, Massachusetts, United States, 02116

Watertown

Neurocrine Clinical Site, Watertown, Massachusetts, United States, 02472

Avon Lake

Neurocrine Clinical Site, Avon Lake, Ohio, United States, 44012

Everett

Neurocrine Clinical Site, Everett, Washington, United States, 98201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neurocrine Biosciences,

Clinical Development Lead, STUDY_DIRECTOR, Neurocrine Biosciences

Study Record Dates

2027-07