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

NCT06966401 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: NBI-1065845-MDD30282024-519423-24-00
• Study Type: interventional
• Target: 850
• Locations: 16 countries
• Sites: 87

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

MDD; Depression; Major Depressive Disorder; NBI-1065845; TAK-653

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Baseline through Week 52

Study Arms (1)

NBI-1065845

EXPERIMENTAL

NBI-1065845 administered orally once a day.

Drug: NBI-1065845

Interventions

NBI-1065845 DRUG

NBI-1065845 tablets

Also known as: TAK-653

NBI-1065845

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (87)

Neurocrine Clinical Site

Huntsville, Alabama, 35801, United States

RECRUITING

Neurocrine Clinical Site

Bryant, Arkansas, 72022, United States

RECRUITING

Neurocrine Clinical Site

Little Rock, Arkansas, 72204, United States

RECRUITING

Neurocrine Clinical Site

Glendale, California, 91206, United States

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Neurocrine Clinical Site

Los Angeles, California, 90025, United States

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Neurocrine Clinical Site

Oceanside, California, 92056, United States

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Neurocrine Clinical Site

Orange, California, 92866, United States

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Neurocrine Clinical Site

Pico Rivera, California, 90660, United States

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Neurocrine Clinical Site

San Diego, California, 92103-8229, United States

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Neurocrine Clinical Site

Upland, California, 91786, United States

TERMINATED

Neurocrine Clinical Site

Cromwell, Connecticut, 06416, United States

RECRUITING

Neurocrine Clinical Site

Farmington, Connecticut, 06030, United States

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Neurocrine Clinical Site

Hollywood, Florida, 33024, United States

RECRUITING

Neurocrine Clinical Site

Maitland, Florida, 32751-5669, United States

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Neurocrine Clinical Site

Maitland, Florida, 32751, United States

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Neurocrine Clinical Site

Miami, Florida, 33174, United States

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Neurocrine Clinical Site

Miami Gardens, Florida, 33014, United States

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Neurocrine Clinical Site

Palm Bay, Florida, 32905, United States

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Neurocrine Clinical Site

Tampa, Florida, 33607, United States

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Neurocrine Clinical Site

Tampa, Florida, 33629, United States

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Neurocrine Clinical Site

Atlanta, Georgia, 30318, United States

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Neurocrine Clinical Site

Gaithersburg, Maryland, 20877, United States

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Neurocrine Clinical Site

Boston, Massachusetts, 02116, United States

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Neurocrine Clinical Site

Watertown, Massachusetts, 02472, United States

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Neurocrine Clinical Site

O'Fallon, Missouri, 63368, United States

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Neurocrine Clinical Site

Saint Charles, Missouri, 63304, United States

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Neurocrine Clinical Site

Cedarhurst, New York, 11516, United States

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Neurocrine Clinical Site

Mount Kisco, New York, 10549, United States

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Neurocrine Clinical Site

New York, New York, 10029, United States

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Neurocrine Clinical Site

New York, New York, 10128, United States

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Neurocrine Clinical Site

The Bronx, New York, 10461, United States

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Neurocrine Clinical Site

Avon Lake, Ohio, 44012, United States

RECRUITING

Neurocrine Clinical Site

Edmond, Oklahoma, 73013, United States

RECRUITING

Neurocrine Clinical Site

Philadelphia, Pennsylvania, 19104, United States

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Neurocrine Clinical Site

Dallas, Texas, 75251, United States

RECRUITING

Neurocrine Clinical Site

Houston, Texas, 77030, United States

RECRUITING

Neurocrine Clinical Site

Richmond, Texas, 77407, United States

WITHDRAWN

Neurocrine Clinical Site

Stafford, Texas, 77477, United States

RECRUITING

Neurocrine Clinical Site

The Woodlands, Texas, 77381, United States

RECRUITING

Neurocrine Clinical Site

Everett, Washington, 98201, United States

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Neurocrine Clinical Site

Alken, 3570, Belgium

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Neurocrine Clinical Site

Mechelen, 2800, Belgium

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Neurocrine Clinical Site

Plovdiv, 4400, Bulgaria

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Neurocrine Clinical Site

Sofia, 1113, Bulgaria

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Neurocrine Clinical Site

Sofia, 1408, Bulgaria

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Neurocrine Clinical Site

Sofia, 1510, Bulgaria

RECRUITING

Neurocrine Clinical Site

Sofia, 1680, Bulgaria

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Neurocrine Clinical Site

Varna, 9020, Bulgaria

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Neurocrine Clinical Site

Zagreb, 10000, Croatia

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Neurocrine Clinical Site

Zagreb, 10090, Croatia

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Neurocrine Clinical Site

Pilsen, 30100, Czechia

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Neurocrine Clinical Site

Prague, 100 00, Czechia

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Neurocrine Clinical Site

Prague, 11000, Czechia

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Neurocrine Clinical Site

Prague, 160 00, Czechia

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Neurocrine Clinical Site

Prague, 186 00, Czechia

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Neurocrine Clinical Site

Tallinn, 11315, Estonia

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Neurocrine Clinical Site

Kuopio, 70110, Finland

RECRUITING

Neurocrine Clinical Site

Oulu, 90100, Finland

RECRUITING

Neurocrine Clinical Site

Tampere, 33210, Finland

RECRUITING

Neurocrine Clinical Site

Budapest, 1036, Hungary

RECRUITING

Neurocrine

Sigulda, Lativa, LV-2150, Latvia

RECRUITING

Neurocrine Clinical Site

Jelgava, LV-3008, Latvia

RECRUITING

Neurocrine Clinical Site

Liepāja, LV-3401, Latvia

RECRUITING

Neurocrine Clinical Site

Kaunas, LT-44279, Lithuania

RECRUITING

Neurocrine Clinical Site

Amsterdam, 1081 GN, Netherlands

NOT YET RECRUITING

Neurocrine Clinical Site

Groningen, 9713 GZ, Netherlands

NOT YET RECRUITING

Neurocrine Clinical Site

Leiden, 2333 ZA, Netherlands

NOT YET RECRUITING

Neurocrine Clinical Site

Bełchatów, 97-400, Poland

RECRUITING

Neurocrine Clinical Site

Bialystok, 15-404, Poland

RECRUITING

Neurocrine Clinical Site

Bialystok, 15-756, Poland

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Neurocrine Clinical Site

Bydgoszcz, 85-794, Poland

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Neurocrine Clinical Site

Gdansk, 80-283, Poland

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Neurocrine Clinical Site

Gdansk, 80-546, Poland

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Neurocrine Clinical Site

Grudziądz, 86-300, Poland

RECRUITING

Neurocrine Clinical Site

Katowice, 40-514, Poland

RECRUITING

Neurocrine Clinical Site

Craiova, 200157, Romania

RECRUITING

Neurocrine Clinical Site

Bojnice, 97201, Slovakia

RECRUITING

Neurocrine Clinical Site

Bratislava, 820 07, Slovakia

RECRUITING

Neurocrine Clinical Site

Košice, 04001, Slovakia

RECRUITING

Neurocrine Clinical Site

Rimavská Sobota, 979 01, Slovakia

RECRUITING

Neurocrine Clinical Site

Svidník, 089 01, Slovakia

RECRUITING

Neurocrine Clinical Site

Vranov nad Topľou, 093 01, Slovakia

RECRUITING

Neurocrine Clinical Site

Gothenburg, 41345, Sweden

RECRUITING

Neurocrine Clinical Site

Lund, 222 22, Sweden

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Neurocrine Clinical Site

Stockholm, 113 29, Sweden

RECRUITING

Neurocrine Clinical Site

Sheffield, South Yorkshire, S3 7ND, United Kingdom

RECRUITING

Neurocrine Clinical Site

London, SE5 8AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Clinical Development Lead

  Neurocrine Biosciences

  STUDY DIRECTOR

Central Study Contacts

Neurocrine Medical Information Call Center

CONTACT

1-877-641-3461; medinfo@neurocrine.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 11, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (40); HU (1); SL (6); CR (2); LA (3); SE (3); RO (1); CZ (5); LI (1); NL (3); GB (2); BU (6); FI (3); ES (1); BE (2); PL (8)