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

April 20, 2026 updated by: Neurocrine Biosciences

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Alken, Belgium, 3570
        • Recruiting
        • Neurocrine Clinical Site
      • Mechelen, Belgium, 2800
        • Recruiting
        • Neurocrine Clinical Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4400
        • Recruiting
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1113
        • Recruiting
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1408
        • Recruiting
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1510
        • Recruiting
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Neurocrine Clinical Site
      • Varna, Bulgaria, 9020
        • Recruiting
        • Neurocrine Clinical Site
  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • Neurocrine Clinical Site
      • Zagreb, Croatia, 10090
        • Recruiting
        • Neurocrine Clinical Site
  • Czechia
      • Pilsen, Czechia, 30100
        • Recruiting
        • Neurocrine Clinical Site
      • Prague, Czechia, 100 00
        • Recruiting
        • Neurocrine Clinical Site
      • Prague, Czechia, 11000
        • Recruiting
        • Neurocrine Clinical Site
      • Prague, Czechia, 160 00
        • Recruiting
        • Neurocrine Clinical Site
      • Prague, Czechia, 186 00
        • Recruiting
        • Neurocrine Clinical Site
  • Estonia
      • Tallinn, Estonia, 11315
        • Recruiting
        • Neurocrine Clinical Site
  • Finland
      • Kuopio, Finland, 70110
        • Recruiting
        • Neurocrine Clinical Site
      • Oulu, Finland, 90100
        • Recruiting
        • Neurocrine Clinical Site
      • Tampere, Finland, 33210
        • Recruiting
        • Neurocrine Clinical Site
  • Hungary
      • Budapest, Hungary, 1036
        • Recruiting
        • Neurocrine Clinical Site
  • Latvia
      • Jelgava, Latvia, LV-3008
        • Recruiting
        • Neurocrine Clinical Site
      • Liepāja, Latvia, LV-3401
        • Recruiting
        • Neurocrine Clinical Site
    • Lativa
      • Sigulda, Lativa, Latvia, LV-2150
        • Recruiting
        • Neurocrine
  • Lithuania
      • Kaunas, Lithuania, LT-44279
        • Recruiting
        • Neurocrine Clinical Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 GN
        • Not yet recruiting
        • Neurocrine Clinical Site
      • Groningen, Netherlands, 9713 GZ
        • Not yet recruiting
        • Neurocrine Clinical Site
      • Leiden, Netherlands, 2333 ZA
        • Not yet recruiting
        • Neurocrine Clinical Site
  • Poland
      • Bełchatów, Poland, 97-400
        • Recruiting
        • Neurocrine Clinical Site
      • Bialystok, Poland, 15-404
        • Recruiting
        • Neurocrine Clinical Site
      • Bialystok, Poland, 15-756
        • Recruiting
        • Neurocrine Clinical Site
      • Bydgoszcz, Poland, 85-794
        • Recruiting
        • Neurocrine Clinical Site
      • Gdansk, Poland, 80-283
        • Recruiting
        • Neurocrine Clinical Site
      • Gdansk, Poland, 80-546
        • Recruiting
        • Neurocrine Clinical Site
      • Grudziądz, Poland, 86-300
        • Recruiting
        • Neurocrine Clinical Site
      • Katowice, Poland, 40-514
        • Recruiting
        • Neurocrine Clinical Site
  • Romania
      • Craiova, Romania, 200157
        • Recruiting
        • Neurocrine Clinical Site
  • Slovakia
      • Bojnice, Slovakia, 97201
        • Recruiting
        • Neurocrine Clinical Site
      • Bratislava, Slovakia, 820 07
        • Recruiting
        • Neurocrine Clinical Site
      • Košice, Slovakia, 04001
        • Recruiting
        • Neurocrine Clinical Site
      • Rimavská Sobota, Slovakia, 979 01
        • Recruiting
        • Neurocrine Clinical Site
      • Svidník, Slovakia, 089 01
        • Recruiting
        • Neurocrine Clinical Site
      • Vranov nad Topľou, Slovakia, 093 01
        • Recruiting
        • Neurocrine Clinical Site
  • Sweden
      • Gothenburg, Sweden, 41345
        • Recruiting
        • Neurocrine Clinical Site
      • Lund, Sweden, 222 22
        • Recruiting
        • Neurocrine Clinical Site
      • Stockholm, Sweden, 113 29
        • Recruiting
        • Neurocrine Clinical Site
  • United Kingdom
      • London, United Kingdom, SE5 8AF
        • Recruiting
        • Neurocrine Clinical Site
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S3 7ND
        • Recruiting
        • Neurocrine Clinical Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Neurocrine Clinical Site
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Recruiting
        • Neurocrine Clinical Site
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Neurocrine Clinical Site
    • California
      • Glendale, California, United States, 91206
        • Recruiting
        • Neurocrine Clinical Site
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Neurocrine Clinical Site
      • Oceanside, California, United States, 92056
        • Recruiting
        • Neurocrine Clinical Site
      • Orange, California, United States, 92866
        • Recruiting
        • Neurocrine Clinical Site
      • Pico Rivera, California, United States, 90660
        • Recruiting
        • Neurocrine Clinical Site
      • San Diego, California, United States, 92103-8229
        • Recruiting
        • Neurocrine Clinical Site
      • Upland, California, United States, 91786
        • Terminated
        • Neurocrine Clinical Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Recruiting
        • Neurocrine Clinical Site
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • Neurocrine Clinical Site
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Neurocrine Clinical Site
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Neurocrine Clinical Site
      • Maitland, Florida, United States, 32751-5669
        • Recruiting
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33174
        • Recruiting
        • Neurocrine Clinical Site
      • Miami Gardens, Florida, United States, 33014
        • Recruiting
        • Neurocrine Clinical Site
      • Palm Bay, Florida, United States, 32905
        • Recruiting
        • Neurocrine Clinical Site
      • Tampa, Florida, United States, 33629
        • Recruiting
        • Neurocrine Clinical Site
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Neurocrine Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Neurocrine Clinical Site
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Recruiting
        • Neurocrine Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Recruiting
        • Neurocrine Clinical Site
      • Watertown, Massachusetts, United States, 02472
        • Recruiting
        • Neurocrine Clinical Site
    • Missouri
      • O'Fallon, Missouri, United States, 63368
        • Recruiting
        • Neurocrine Clinical Site
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Neurocrine Clinical Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Recruiting
        • Neurocrine Clinical Site
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Neurocrine Clinical Site
      • New York, New York, United States, 10029
        • Recruiting
        • Neurocrine Clinical Site
      • New York, New York, United States, 10128
        • Recruiting
        • Neurocrine Clinical Site
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Neurocrine Clinical Site
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Recruiting
        • Neurocrine Clinical Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Recruiting
        • Neurocrine Clinical Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Neurocrine Clinical Site
    • Texas
      • Dallas, Texas, United States, 75251
        • Recruiting
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Neurocrine Clinical Site
      • Richmond, Texas, United States, 77407
        • Withdrawn
        • Neurocrine Clinical Site
      • Stafford, Texas, United States, 77477
        • Recruiting
        • Neurocrine Clinical Site
      • The Woodlands, Texas, United States, 77381
        • Recruiting
        • Neurocrine Clinical Site
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NBI-1065845
NBI-1065845 administered orally once a day.
Drug: NBI-1065845
NBI-1065845 tablets
Other Names:
  • TAK-653

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Baseline through Week 52
Baseline through Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2025

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-1065845-MDD3028
  • 2024-519423-24-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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