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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
In plain English
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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: 600 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-16
Estimated completion: 2030-05
Last updated: 2025-08-01
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 (18)
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Little Rock, Arkansas, United States
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Orange, California, United States
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Pico Rivera, California, United States
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Upland, California, United States
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Hollywood, Florida, United States
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Maitland, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Boston, Massachusetts, United States
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Watertown, Massachusetts, United States
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Saint Charles, Missouri, United States
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Mount Kisco, 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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Dallas, Texas, United States
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Richmond, Texas, United States
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The Woodlands, Texas, United States
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Everett, Washington, United States