RecruitingPhase 3NCT06963021

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

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)

Sponsor

Neurocrine Biosciences

Enrollment

200 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new medication (NBI-1065845) for people with difficult-to-treat depression — specifically, those who have not improved enough with standard antidepressant pills. Participants will continue taking their current antidepressant and add the study drug to see if their symptoms improve more. **You may be eligible if...** - You have been diagnosed with recurrent major depressive disorder (moderate or severe) or persistent depressive disorder (chronic low mood) - You have not responded adequately to your current antidepressant medication after at least 8 weeks - You are willing to continue your current antidepressant at the same dose throughout the study - Your depression symptoms are severe at the start of the study (Hamilton Depression Rating Scale score of 22 or higher) **You may NOT be eligible if...** - You have another primary psychiatric diagnosis that was the main focus of your treatment in the past year - You are considered to be at risk of harming yourself or others - Your depression did not respond to electroconvulsive therapy (ECT) in the current episode Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNBI-1065845

NBI-1065845 tablets

DRUGPlacebo

Matching placebo tablets

Locations(30)

Neurocrine Clinical Site

Chino, California, United States

Neurocrine Clinical Site

Los Angeles, California, United States

Neurocrine Clinical Site

Stanford, California, United States

Neurocrine Clinical Site

Aurora, Colorado, United States

Neurocrine Clinical Site

Cromwell, Connecticut, United States

Neurocrine Clinical Site

Farmington, Connecticut, United States

Neurocrine Clinical Site

Maitland, Florida, United States

Neurocrine Clinical Site

Miami, Florida, United States

Neurocrine Clinical Site

Tampa, Florida, United States

Neurocrine Clinical Site

Gaithersburg, Maryland, United States

Neurocrine Clinical Site

Cedarhurst, New York, United States

Neurocrine Clinical Site

New York, New York, United States

Neurocrine Clinical Site

New York, New York, United States

Neurocrine Clinical Site

Philadelphia, Pennsylvania, United States

Neurocrine Clinical Site

Alken, Belgium

Neurocrine Clinical Site

Bruges, Belgium

Neurocrine Clinical Site

Mechelen, Belgium

Neurocrine Clinical Site

Toronto, Ontario, Canada

Neurocrine Clinical Site

Kuopio, Finland

Neurocrine Clinical Site

Oulu, Finland

Neurocrine Clinical Site

Tampere, Finland

Neurocrine Clinical Site

Budapest, Hungary

Neurocrine Clinical Site

Budapest, Hungary

Neurocrine Clinical Site

Gyöngyös, Hungary

Neurocrine Clinical Site

Jelgava, Latvia

Neurocrine Clinical Site

Liepāja, Latvia

Neurocrine Clinical Site

Sigulda, Latvia

Neurocrine Clinical Site

Manchester, United Kingdom

Neurocrine Clinical Site

Sheffield, United Kingdom

Neurocrine Clinical Site

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06963021

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(30)

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