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NCT06966401PHASE3Recruiting

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

Neurocrine Biosciences

Start Date

4/16/2025

Completion Date

5/1/2030

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

Key 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 prior to screening. * Willing and able to comply with all study procedures and restrictions in the opinion of the investigator. Key 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. Other protocol defined inclusion and exclusion criteria apply.

Interventions

DRUG

NBI-1065845

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Conditions

Major Depressive Disorder

Locations

Neurocrine Clinical Site

Huntsville, Alabama 35801

United States

Neurocrine Clinical Site

Bryant, Arkansas 72022

United States

Neurocrine Clinical Site

Little Rock, Arkansas 72204

United States

Neurocrine Clinical Site

Glendale, California 91206

United States

Neurocrine Clinical Site

Los Angeles, California 90025

United States

Neurocrine Clinical Site

Oceanside, California 92056

United States

Neurocrine Clinical Site

Orange, California 92866

United States

Neurocrine Clinical Site

Pico Rivera, California 90660

United States

Neurocrine Clinical Site

San Diego, California 92103-8229

United States

Neurocrine Clinical Site

San Francisco, California 94107

United States

Neurocrine Clinical Site

San Jose, California 95124

United States

Neurocrine Clinical Site

Upland, California 91786

United States

Neurocrine Clinical Site

Cromwell, Connecticut 06416

United States

Neurocrine Clinical Site

Farmington, Connecticut 06030

United States

Neurocrine Clinical Site

Hollywood, Florida 33024

United States

Neurocrine Clinical Site

Maitland, Florida 32751-5669

United States

Neurocrine Clinical Site

Maitland, Florida 32751

United States

Neurocrine Clinical Site

Miami, Florida 33174

United States

Neurocrine Clinical Site

Miami Gardens, Florida 33014

United States

Neurocrine Clinical Site

Orlando, Florida 32803

United States

Neurocrine Clinical Site

Palm Bay, Florida 32905

United States

Neurocrine Clinical Site

Tampa, Florida 33607

United States

Neurocrine Clinical Site

Tampa, Florida 33629

United States

Neurocrine Clinical Site

Atlanta, Georgia 30318

United States

Neurocrine Clinical Site

Gaithersburg, Maryland 20877

United States

Neurocrine Clinical Site

Boston, Massachusetts 02116

United States

Neurocrine Clinical Site

Watertown, Massachusetts 02472

United States

Neurocrine Clinical Site

O'Fallon, Missouri 63368

United States

Neurocrine Clinical Site

Saint Charles, Missouri 63304

United States

Neurocrine Clinical Site

Cedarhurst, New York 11516

United States

Neurocrine Clinical Site

Mount Kisco, New York 10549

United States

Neurocrine Clinical Site

New York, New York 10029

United States

Neurocrine Clinical Site

New York, New York 10128

United States

Neurocrine Clinical Site

The Bronx, New York 10461

United States

Neurocrine Clinical Site

Avon Lake, Ohio 44012

United States

Neurocrine Clinical Site

Edmond, Oklahoma 73013

United States

Neurocrine Clinical Site

Oklahoma City, Oklahoma 73112

United States

Neurocrine Clinical Site

Philadelphia, Pennsylvania 19104

United States

Neurocrine Clinical Site

Bellaire, Texas 77401

United States

Neurocrine Clinical Site

Dallas, Texas 75251

United States

Neurocrine Clinical Site

DeSoto, Texas 75115

United States

Neurocrine Clinical Site

Houston, Texas 77030

United States

Neurocrine Clinical Site

Richmond, Texas 77407

United States

Neurocrine Clinical Site

Stafford, Texas 77477

United States

Neurocrine Clinical Site

The Woodlands, Texas 77381

United States

Neurocrine Clinical Site

Everett, Washington 98201

United States

Neurocrine Clinical Site

Alken, 3570

Belgium

Neurocrine Clinical Site

Mechelen, 2800

Belgium

Neurocrine Clinical Site

Kardzhali, 7003

Bulgaria

Neurocrine Clinical Site

Plovdiv, 4400

Bulgaria

Neurocrine Clinical Site

Sofia, 1113

Bulgaria

Neurocrine Clinical Site

Sofia, 1408

Bulgaria

Neurocrine Clinical Site

Sofia, 1510

Bulgaria

Neurocrine Clinical Site

Sofia, 1510

Bulgaria

Neurocrine Clinical Site

Sofia, 1680

Bulgaria

Neurocrine Clinical Site

Varna, 9020

Bulgaria

Neurocrine Clinical Site

Toronto, Ontario M5H 1A1

Canada

Neurocrine Clinical Site

Zagreb, 10000

Croatia

Neurocrine Clinical Site

Zagreb, 10090

Croatia

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Pilsen, 30100

Czechia

Neurocrine Clinical Site

Prague, 100 00

Czechia

Neurocrine Clinical Site

Prague, 11000

Czechia

Neurocrine Clinical Site

Prague, 160 00

Czechia

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Prague, 186 00

Czechia

Neurocrine Clinical Site

Tallinn, 11315

Estonia

Neurocrine Clinical Site

Kuopio, 70110

Finland

Neurocrine Clinical Site

Oulu, 90100

Finland

Neurocrine Clinical Site

Tampere, 33210

Finland

Neurocrine Clinical Site

Budapest, 1036

Hungary

Neurocrine Clinical Site

Roma, 00168

Italy

Neurocrine Clinical Site

Jelgava, Lativa LV-3008

Latvia

Neurocrine Clinical Site

Liepāja, Lativa LV-3401

Latvia

Neurocrine

Sigulda, Lativa LV-2150

Latvia

Neurocrine Clinical Site

Jelgava, LV-3008

Latvia

Neurocrine Clinical Site

Liepāja, LV-3401

Latvia

Neurocrine Clinical Site

Kaunas, LT-44279

Lithuania

Neurocrine Clinical Site

Kaunas, LT-49449

Lithuania

Neurocrine Clinical Site

Amsterdam, 1081 GN

Netherlands

Neurocrine Clinical Site

Groningen, 9713 GZ

Netherlands

Neurocrine Clinical Site

Leiden, 2333 ZA

Netherlands

Neurocrine Clinical Site

Bełchatów, 97-400

Poland

Neurocrine Clinical Site

Bialystok, 15-404

Poland

Neurocrine Clinical Site

Bialystok, 15-756

Poland

Neurocrine Clinical Site

Bialystok, 15-879

Poland

Neurocrine Clinical Site

Bydgoszcz, 85-794

Poland

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Gdansk, 80-283

Poland

Neurocrine Clinical Site

Gdansk, 80-546

Poland

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Grudziądz, 86-300

Poland

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Katowice, 40-514

Poland

Neurocrine Clinical Site

Craiova, 200157

Romania

Neurocrine Clinical Site

Bojnice, 97201

Slovakia

Neurocrine Clinical Site

Bratislava, 820 07

Slovakia

Neurocrine Clinical Site

Košice, 04001

Slovakia

Neurocrine Clinical Site

Rimavská Sobota, 979 01

Slovakia

Neurocrine Clinical Site

Svidník, 089 01

Slovakia

Neurocrine Clinical Site

Vranov nad Topľou, 093 01

Slovakia

Neurocrine Clinical Site

Madrid, 28922

Spain

Neurocrine Clinical Site

Gothenburg, 41345

Sweden

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Lund, 222 22

Sweden

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Stockholm, 113 29

Sweden

Neurocrine Clinical Site

Keelung, 204

Taiwan

Neurocrine Clinical Site

Taipei, 112201

Taiwan

Neurocrine Clinical Site

Southampton, Hampshire SO30 3JB

United Kingdom

Neurocrine Clinical Site

Sheffield, South Yorkshire S3 7ND

United Kingdom

Neurocrine Clinical Site

London, SE5 8AF

United Kingdom

Neurocrine Clinical Site

Manchester, M25 3BL

United Kingdom