RecruitingPhase 3NCT06911112

NBI-1065845-MDD3025: 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

Mar 31, 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 experimental medication called NBI-1065845 as an add-on treatment for people with major depressive disorder (MDD) who have not responded well enough to their current antidepressants. **You may be eligible if...** - You have been diagnosed with recurrent major depression (moderate or severe) or persistent depressive disorder - Your current antidepressant has not been working well enough in this episode - You have been taking an oral antidepressant for at least 8 weeks and are willing to continue it during the study - Your depression scores on a standard rating scale are still significantly elevated **You may NOT be eligible if...** - You have another psychiatric disorder that was the main focus of treatment in the past year (other than depression) - You are considered at risk of harming yourself or others - Your depression has previously not responded to electroconvulsive therapy (ECT) in this 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(39)

Neurocrine Clinical Site

Huntsville, Alabama, United States

Neurocrine Clinical Site

Bryant, Arkansas, United States

Neurocrine Clinical Site

Glendale, California, United States

Neurocrine Clinical Site

Irvine, California, United States

Neurocrine Clinical Site

Redlands, California, United States

Neurocrine Clinical Site

San Francisco, California, United States

Neurocrine Clinical Site

Hollywood, Florida, United States

Neurocrine Clinical Site

Miami, Florida, United States

Neurocrine Clinical Site

Tampa, Florida, United States

Neurocrine Clinical Site

Atlanta, Georgia, United States

Neurocrine Clinical Site

Boston, Massachusetts, United States

Neurocrine Clinical Site

Saint Charles, Missouri, United States

Neurocrine Clinical Site

New York, New York, United States

Neurocrine Clinical Site

The Bronx, New York, United States

Neurocrine Clinical Site

Mason, Ohio, United States

Neurocrine Clinical Site

DeSoto, Texas, United States

Neurocrine Clinical Site

Charlottesville, Virginia, United States

Neurocrine Clinical Site

Kardzhali, Bulgaria

Neurocrine Clinical Site

Plovdiv, Bulgaria

Neurocrine Clinical Site

Rousse, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Varna, Bulgaria

Neurocrine Clinical Site

Kaunas, Lithuania

Neurocrine Clinical Site

Kaunas, Lithuania

Neurocrine Clinical Site

Kaunas, Lithuania

Neurocrine Clinical Site

Klaipėda, Lithuania

Neurocrine Clinical Site

Vilnius, Lithuania

Neurocrine Clinical Site

Bucharest, Romania

Neurocrine Clinical Site

Bucharest, Romania

Neurocrine Clinical Site

Craiova, Romania

Neurocrine Clinical Site

Oradea, Romania

Neurocrine Clinical Site

Banská Bystrica, Slovakia

Neurocrine Clinical Site

Bojnice, Slovakia

Neurocrine Clinical Site

Bratislava, Slovakia

Neurocrine Clinical Site

Košice, Slovakia

Neurocrine Clinical Site

Rimavská Sobota, Slovakia

Neurocrine Clinical Site

Svidník, Slovakia

Neurocrine Clinical Site

Vranov nad Topľou, Slovakia

View Full Details on ClinicalTrials.gov

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NCT06911112

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