RecruitingPhase 3NCT06966401

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

A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Sponsor

Neurocrine Biosciences

Enrollment

850 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

Summary

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This long-term study is evaluating the safety and tolerability of NBI-1065845 — a new add-on medication taken alongside existing antidepressants — in people with major depressive disorder (MDD) who haven't fully responded to standard antidepressant treatments. **You may be eligible if...** - You have a primary diagnosis of recurrent moderate-to-severe major depressive disorder or persistent depressive disorder - Your current antidepressant treatment has not fully worked - You have been taking an oral antidepressant for at least 8 weeks - You are willing and able to follow all study procedures **You may NOT be eligible if...** - You have another psychiatric condition (such as bipolar disorder or schizophrenia) that was the main focus of treatment in the past year - You have active suicidal ideation - You are pregnant or breastfeeding 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

Locations(87)

Neurocrine Clinical Site

Huntsville, Alabama, United States

Neurocrine Clinical Site

Bryant, Arkansas, United States

Neurocrine Clinical Site

Little Rock, Arkansas, United States

Neurocrine Clinical Site

Glendale, California, United States

Neurocrine Clinical Site

Los Angeles, California, United States

Neurocrine Clinical Site

Oceanside, California, United States

Neurocrine Clinical Site

Orange, California, United States

Neurocrine Clinical Site

Pico Rivera, California, United States

Neurocrine Clinical Site

San Diego, California, United States

Neurocrine Clinical Site

Upland, California, United States

Neurocrine Clinical Site

Cromwell, Connecticut, United States

Neurocrine Clinical Site

Farmington, Connecticut, United States

Neurocrine Clinical Site

Hollywood, Florida, United States

Neurocrine Clinical Site

Maitland, Florida, United States

Neurocrine Clinical Site

Maitland, Florida, United States

Neurocrine Clinical Site

Miami, Florida, United States

Neurocrine Clinical Site

Miami Gardens, Florida, United States

Neurocrine Clinical Site

Palm Bay, Florida, United States

Neurocrine Clinical Site

Tampa, Florida, United States

Neurocrine Clinical Site

Tampa, Florida, United States

Neurocrine Clinical Site

Atlanta, Georgia, United States

Neurocrine Clinical Site

Gaithersburg, Maryland, United States

Neurocrine Clinical Site

Boston, Massachusetts, United States

Neurocrine Clinical Site

Watertown, Massachusetts, United States

Neurocrine Clinical Site

O'Fallon, Missouri, United States

Neurocrine Clinical Site

Saint Charles, Missouri, United States

Neurocrine Clinical Site

Cedarhurst, New York, United States

Neurocrine Clinical Site

Mount Kisco, 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

The Bronx, New York, United States

Neurocrine Clinical Site

Avon Lake, Ohio, United States

Neurocrine Clinical Site

Edmond, Oklahoma, United States

Neurocrine Clinical Site

Philadelphia, Pennsylvania, United States

Neurocrine Clinical Site

Dallas, Texas, United States

Neurocrine Clinical Site

Houston, Texas, United States

Neurocrine Clinical Site

Richmond, Texas, United States

Neurocrine Clinical Site

Stafford, Texas, United States

Neurocrine Clinical Site

The Woodlands, Texas, United States

Neurocrine Clinical Site

Everett, Washington, United States

Neurocrine Clinical Site

Alken, Belgium

Neurocrine Clinical Site

Mechelen, Belgium

Neurocrine Clinical Site

Plovdiv, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Sofia, Bulgaria

Neurocrine Clinical Site

Varna, Bulgaria

Neurocrine Clinical Site

Zagreb, Croatia

Neurocrine Clinical Site

Zagreb, Croatia

Neurocrine Clinical Site

Pilsen, Czechia

Neurocrine Clinical Site

Prague, Czechia

Neurocrine Clinical Site

Prague, Czechia

Neurocrine Clinical Site

Prague, Czechia

Neurocrine Clinical Site

Prague, Czechia

Neurocrine Clinical Site

Tallinn, Estonia

Neurocrine Clinical Site

Kuopio, Finland

Neurocrine Clinical Site

Oulu, Finland

Neurocrine Clinical Site

Tampere, Finland

Neurocrine Clinical Site

Budapest, Hungary

Neurocrine

Sigulda, Lativa, Latvia

Neurocrine Clinical Site

Jelgava, Latvia

Neurocrine Clinical Site

Liepāja, Latvia

Neurocrine Clinical Site

Kaunas, Lithuania

Neurocrine Clinical Site

Amsterdam, Netherlands

Neurocrine Clinical Site

Groningen, Netherlands

Neurocrine Clinical Site

Leiden, Netherlands

Neurocrine Clinical Site

Bełchatów, Poland

Neurocrine Clinical Site

Bialystok, Poland

Neurocrine Clinical Site

Bialystok, Poland

Neurocrine Clinical Site

Bydgoszcz, Poland

Neurocrine Clinical Site

Gdansk, Poland

Neurocrine Clinical Site

Gdansk, Poland

Neurocrine Clinical Site

Grudziądz, Poland

Neurocrine Clinical Site

Katowice, Poland

Neurocrine Clinical Site

Craiova, Romania

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

Neurocrine Clinical Site

Gothenburg, Sweden

Neurocrine Clinical Site

Lund, Sweden

Neurocrine Clinical Site

Stockholm, Sweden

Neurocrine Clinical Site

Sheffield, South Yorkshire, United Kingdom

Neurocrine Clinical Site

London, United Kingdom

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NCT06966401

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(87)

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