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A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Sponsor: Neurocrine Biosciences
Summary
The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
550
Start Date
2025-08-18
Completion Date
2028-07
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
NBI-1065845
Oral tablet
Placebo
Oral tablet
Locations (45)
Neurocrine Clinical Site
Oceanside, California, United States
Neurocrine Clinical Site
San Jose, California, United States
Neurocrine Clinical Site
New Haven, Connecticut, United States
Neurocrine Clinical Site
Miami Gardens, Florida, United States
Neurocrine Clinical Site
Orlando, Florida, United States
Neurocrine Clinical Site
Palm Bay, Florida, United States
Neurocrine Clinical Site
Tampa, Florida, United States
Neurocrine Clinical Site
Marrero, Louisiana, United States
Neurocrine Clinical Site
O'Fallon, Missouri, United States
Neurocrine Clinical Site
Albuquerque, New Mexico, United States
Neurocrine Clinical Site
Charlotte, North Carolina, United States
Neurocrine Clinical Site
Edmond, Oklahoma, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States
Neurocrine Clinical Site
Bellaire, Texas, United States
Neurocrine Clinical Site
Friendswood, Texas, United States
Neurocrine Clinical Site
Stafford, Texas, United States
Neurocrine Clinical Site
Wichita Falls, Texas, United States
Neurocrine Clinical Site
Draper, Utah, United States
Neurocrine Clinical Site
Carlton, Victoria, Australia
Neurocrine Clinical Site
Sofia, Bulgaria
Neurocrine Clinical Site
Sofia, Bulgaria
Neurocrine Clinical Site
Sofia, Bulgaria
Neurocrine Clinical Site
Sofia, Bulgaria
Neurocrine Clinical Site
North Vancouver, British Columbia, Canada
Neurocrine Clinical Site
Sherbrooke, Quebec, Canada
Neurocrine Clinical Site
Toronto, Canada
Neurocrine Clinical Site
Tallinn, Estonia
Neurocrine Clinical Site
Tallinn, Estonia
Neurocrine Clinical Site
Tartu, Estonia
Neurocrine Clinical Site
Milan, Italy
Neurocrine Clinical Site
Rome, Italy
Neurocrine Clinical Site
Bialystok, Poland
Neurocrine Clinical Site
Bydgoszcz, Poland
Neurocrine Clinical Site
Gdansk, Poland
Neurocrine Clinical Site
Belgrade, Serbia
Neurocrine Clinical Site
Kovin, Serbia
Neurocrine Clinical Site
Ansan-si, Gyeonggi-do, South Korea
Neurocrine Clinical Site
Seoul, South Korea
Neurocrine Clinical Site
Seoul, South Korea
Neurocrine Clinical Site
Alcorcón, Madrid, Spain
Neurocrine Clinical Site
Barcelona, Spain
Neurocrine Clinical Site
Keelung, Taiwan
Neurocrine Clinical Site
Taipei, Taiwan
Neurocrine Clinical Site
Taipei, Taiwan
Neurocrine Clinical Site
Taipei, Taiwan