Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Launched by NEUROCRINE BIOSCIENCES · May 7, 2025
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called NBI-1065845 to see how safe it is and how well people can tolerate it when used alongside other treatments for Major Depressive Disorder (MDD). MDD is a serious condition that can cause persistent feelings of sadness and loss of interest in activities. The trial is designed for individuals aged 65 to 74 who have been diagnosed with either recurrent MDD or persistent depressive disorder, and who haven't seen improvement with their current oral antidepressant medication after at least 8 weeks of treatment.
Participants in this study can expect to undergo regular check-ups and follow specific guidelines set by the researchers. It’s important to know that those who have other major psychiatric conditions or are at risk of harming themselves or others won’t be eligible to join. This trial is not yet recruiting participants, so there’s still time to learn more and see if it might be a good option for you or a loved one who is struggling with MDD.
Gender
ALL
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.
About Neurocrine Biosciences
Neurocrine Biosciences is a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for neurological and endocrine disorders. With a strong focus on addressing unmet medical needs, Neurocrine leverages cutting-edge science and technology to advance its pipeline of potential treatments. The company collaborates closely with healthcare professionals, research institutions, and patient communities to ensure that its clinical trials are designed with the highest standards of ethics and efficacy. Committed to improving patient outcomes, Neurocrine's mission is to transform the lives of those affected by debilitating conditions through groundbreaking research and development.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Everett, Washington, United States
Richmond, Texas, United States
Pico Rivera, California, United States
Saint Charles, Missouri, United States
Hollywood, Florida, United States
Orange, California, United States
Boston, Massachusetts, United States
Watertown, Massachusetts, United States
Avon Lake, Ohio, United States
Little Rock, Arkansas, United States
Upland, California, United States
Maitland, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Bronx, New York, United States
Mount Kisco, New York, United States
Dallas, Texas, United States
The Woodlands, Texas, United States
Patients applied
Trial Officials
Clinical Development Lead
Study Director
Neurocrine Biosciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported