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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)

NCT06966401 · Neurocrine Biosciences
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Official title
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)
About this study
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Eligibility criteria
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 design
Enrollment target: 850 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-16
Estimated completion: 2030-05
Last updated: 2026-04-23
Interventions
Drug: NBI-1065845
Primary outcomes
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Baseline through Week 52)
Sponsor
Neurocrine Biosciences · industry
Contacts & investigators
ContactNeurocrine Medical Information Call Center · contact · medinfo@neurocrine.com · 1-877-641-3461
InvestigatorClinical Development Lead · study_director, Neurocrine Biosciences
All locations (87)
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Huntsville, Alabama, United States
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Bryant, Arkansas, United States
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Little Rock, Arkansas, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Pico Rivera, California, United States
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San Diego, California, United States
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Upland, California, United States
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Cromwell, Connecticut, United States
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Farmington, Connecticut, United States
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Hollywood, Florida, United States
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Maitland, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Miami Gardens, Florida, United States
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Palm Bay, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Gaithersburg, Maryland, United States
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Boston, Massachusetts, United States
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Watertown, Massachusetts, United States
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O'Fallon, Missouri, United States
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Saint Charles, Missouri, United States
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Cedarhurst, New York, United States
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Mount Kisco, New York, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Avon Lake, Ohio, United States
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Edmond, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Richmond, Texas, United States
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Stafford, Texas, United States
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The Woodlands, Texas, United States
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Everett, Washington, United States
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Alken, Belgium
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Mechelen, Belgium
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Zagreb, Croatia
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Zagreb, Croatia
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Pilsen, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Tallinn, Estonia
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Kuopio, Finland
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Oulu, Finland
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Tampere, Finland
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Budapest, Hungary
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Sigulda, Lativa, Latvia
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Jelgava, Latvia
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Liepāja, Latvia
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Kaunas, Lithuania
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Amsterdam, Netherlands
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Groningen, Netherlands
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Leiden, Netherlands
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Bełchatów, Poland
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Bialystok, Poland
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Bialystok, Poland
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Bydgoszcz, Poland
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Gdansk, Poland
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Gdansk, Poland
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Grudziądz, Poland
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Katowice, Poland
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Craiova, Romania
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Bojnice, Slovakia
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Bratislava, Slovakia
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Košice, Slovakia
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Rimavská Sobota, Slovakia
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Svidník, Slovakia
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Vranov nad Topľou, Slovakia
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Gothenburg, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Sheffield, South Yorkshire, United Kingdom
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London, United Kingdom
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) · TrialPath