Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
July 22, 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
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
- Name: Neurocrine Medical Information Call Center
- Phone Number: 1-877-641-3461
- Email: medinfo@neurocrine.com
Study Locations
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Alken, Belgium, 3570
- Recruiting
- Neurocrine Clinical Site
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Mechelen, Belgium, 2800
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- Neurocrine Clinical Site
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Kardzhali, Bulgaria, 7003
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- Neurocrine Clinical Site
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Plovdiv, Bulgaria, 4400
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- Neurocrine Clinical Site
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Sofia, Bulgaria, 1113
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- Neurocrine Clinical Site
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Sofia, Bulgaria, 1408
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- Neurocrine Clinical Site
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Sofia, Bulgaria, 1510
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- Neurocrine Clinical Site
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Sofia, Bulgaria, 1680
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- Neurocrine Clinical Site
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Sofia, Bulgaria, 1510
- Withdrawn
- Neurocrine Clinical Site
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Varna, Bulgaria, 9020
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- Neurocrine Clinical Site
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Ontario
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Toronto, Ontario, Canada, M5H 1A1
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- Neurocrine Clinical Site
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Zagreb, Croatia, 10000
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- Neurocrine Clinical Site
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Zagreb, Croatia, 10090
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- Neurocrine Clinical Site
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Pilsen, Czechia, 30100
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- Neurocrine Clinical Site
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Prague, Czechia, 100 00
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- Neurocrine Clinical Site
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Prague, Czechia, 11000
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- Neurocrine Clinical Site
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Prague, Czechia, 160 00
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- Neurocrine Clinical Site
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Prague, Czechia, 186 00
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- Neurocrine Clinical Site
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Tallinn, Estonia, 11315
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- Neurocrine Clinical Site
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Kuopio, Finland, 70110
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- Neurocrine Clinical Site
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Oulu, Finland, 90100
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- Neurocrine Clinical Site
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Tampere, Finland, 33210
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- Neurocrine Clinical Site
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Budapest, Hungary, 1036
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- Neurocrine Clinical Site
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Roma, Italy, 00168
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- Neurocrine Clinical Site
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Jelgava, Latvia, LV-3008
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- Neurocrine Clinical Site
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Liepāja, Latvia, LV-3401
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- Neurocrine Clinical Site
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Lativa
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Jelgava, Lativa, Latvia, LV-3008
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- Neurocrine Clinical Site
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Liepāja, Lativa, Latvia, LV-3401
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- Neurocrine Clinical Site
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Sigulda, Lativa, Latvia, LV-2150
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- Neurocrine
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Kaunas, Lithuania, LT-44279
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- Neurocrine Clinical Site
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Kaunas, Lithuania, LT-49449
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Amsterdam, Netherlands, 1081 GN
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- Neurocrine Clinical Site
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Groningen, Netherlands, 9713 GZ
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- Neurocrine Clinical Site
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Leiden, Netherlands, 2333 ZA
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- Neurocrine Clinical Site
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Bełchatów, Poland, 97-400
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- Neurocrine Clinical Site
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Bialystok, Poland, 15-404
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- Neurocrine Clinical Site
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Bialystok, Poland, 15-756
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- Neurocrine Clinical Site
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Bialystok, Poland, 15-879
- Withdrawn
- Neurocrine Clinical Site
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Bydgoszcz, Poland, 85-794
- Recruiting
- Neurocrine Clinical Site
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Gdansk, Poland, 80-283
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- Neurocrine Clinical Site
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Gdansk, Poland, 80-546
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- Neurocrine Clinical Site
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Grudziądz, Poland, 86-300
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- Neurocrine Clinical Site
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Katowice, Poland, 40-514
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- Neurocrine Clinical Site
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Craiova, Romania, 200157
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- Neurocrine Clinical Site
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Bojnice, Slovakia, 97201
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- Neurocrine Clinical Site
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Bratislava, Slovakia, 820 07
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- Neurocrine Clinical Site
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Košice, Slovakia, 04001
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- Neurocrine Clinical Site
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Rimavská Sobota, Slovakia, 979 01
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- Neurocrine Clinical Site
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Svidník, Slovakia, 089 01
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- Neurocrine Clinical Site
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Vranov nad Topľou, Slovakia, 093 01
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- Neurocrine Clinical Site
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Madrid, Spain, 28922
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- Neurocrine Clinical Site
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Gothenburg, Sweden, 41345
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- Neurocrine Clinical Site
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Lund, Sweden, 222 22
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Stockholm, Sweden, 113 29
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- Neurocrine Clinical Site
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Keelung, Taiwan, 204
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- Neurocrine Clinical Site
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Taipei, Taiwan, 112201
- Withdrawn
- Neurocrine Clinical Site
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London, United Kingdom, SE5 8AF
- Recruiting
- Neurocrine Clinical Site
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Manchester, United Kingdom, M25 3BL
- Withdrawn
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Hampshire
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Southampton, Hampshire, United Kingdom, SO30 3JB
- Withdrawn
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South Yorkshire
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Sheffield, South Yorkshire, United Kingdom, S3 7ND
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- Neurocrine Clinical Site
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Alabama
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Huntsville, Alabama, United States, 35801
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- Neurocrine Clinical Site
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Arkansas
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Bryant, Arkansas, United States, 72022
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- Neurocrine Clinical Site
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Little Rock, Arkansas, United States, 72204
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- Neurocrine Clinical Site
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California
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Glendale, California, United States, 91206
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- Neurocrine Clinical Site
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Los Angeles, California, United States, 90025
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- Neurocrine Clinical Site
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Oceanside, California, United States, 92056
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- Neurocrine Clinical Site
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Orange, California, United States, 92866
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- Neurocrine Clinical Site
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Pico Rivera, California, United States, 90660
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- Neurocrine Clinical Site
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San Diego, California, United States, 92103-8229
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- Neurocrine Clinical Site
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San Francisco, California, United States, 94107
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- Neurocrine Clinical Site
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San Jose, California, United States, 95124
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- Neurocrine Clinical Site
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Upland, California, United States, 91786
- Terminated
- Neurocrine Clinical Site
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Connecticut
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Cromwell, Connecticut, United States, 06416
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- Neurocrine Clinical Site
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Farmington, Connecticut, United States, 06030
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- Neurocrine Clinical Site
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Florida
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Hollywood, Florida, United States, 33024
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- Neurocrine Clinical Site
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Maitland, Florida, United States, 32751
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- Neurocrine Clinical Site
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Maitland, Florida, United States, 32751-5669
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- Neurocrine Clinical Site
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Miami, Florida, United States, 33174
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- Neurocrine Clinical Site
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Miami Gardens, Florida, United States, 33014
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- Neurocrine Clinical Site
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Orlando, Florida, United States, 32803
- Withdrawn
- Neurocrine Clinical Site
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Palm Bay, Florida, United States, 32905
- Recruiting
- Neurocrine Clinical Site
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Tampa, Florida, United States, 33629
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- Neurocrine Clinical Site
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Tampa, Florida, United States, 33607
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- Neurocrine Clinical Site
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Georgia
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Atlanta, Georgia, United States, 30318
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- Neurocrine Clinical Site
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Maryland
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Gaithersburg, Maryland, United States, 20877
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- Neurocrine Clinical Site
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Massachusetts
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Boston, Massachusetts, United States, 02116
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- Neurocrine Clinical Site
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Watertown, Massachusetts, United States, 02472
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- Neurocrine Clinical Site
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Missouri
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O'Fallon, Missouri, United States, 63368
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- Neurocrine Clinical Site
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Saint Charles, Missouri, United States, 63304
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- Neurocrine Clinical Site
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New York
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Cedarhurst, New York, United States, 11516
- Recruiting
- Neurocrine Clinical Site
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Mount Kisco, New York, United States, 10549
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- Neurocrine Clinical Site
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New York, New York, United States, 10029
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- Neurocrine Clinical Site
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New York, New York, United States, 10128
- Recruiting
- Neurocrine Clinical Site
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The Bronx, New York, United States, 10461
- Recruiting
- Neurocrine Clinical Site
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Ohio
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Avon Lake, Ohio, United States, 44012
- Recruiting
- Neurocrine Clinical Site
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Oklahoma
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Edmond, Oklahoma, United States, 73013
- Recruiting
- Neurocrine Clinical Site
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Oklahoma City, Oklahoma, United States, 73112
- Withdrawn
- Neurocrine Clinical Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Neurocrine Clinical Site
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Texas
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Bellaire, Texas, United States, 77401
- Recruiting
- Neurocrine Clinical Site
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Dallas, Texas, United States, 75251
- Recruiting
- Neurocrine Clinical Site
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DeSoto, Texas, United States, 75115
- Recruiting
- Neurocrine Clinical Site
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Houston, Texas, United States, 77030
- Recruiting
- Neurocrine Clinical Site
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Richmond, Texas, United States, 77407
- Withdrawn
- Neurocrine Clinical Site
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Stafford, Texas, United States, 77477
- Recruiting
- Neurocrine Clinical Site
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The Woodlands, Texas, United States, 77381
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- Neurocrine Clinical Site
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Washington
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Everett, Washington, United States, 98201
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- Neurocrine Clinical Site
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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 |
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Experimental: NBI-1065845
NBI-1065845 administered orally once a day.
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NBI-1065845 tablets
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Baseline through Week 52
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Baseline through Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 24, 2026
Last Update Submitted That Met QC Criteria
July 22, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
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.