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Clinical Trials in the USA / NCT06966401
Recruiting Phase 3

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT06966401 · tracked via the Priya Life Science USA tracker
Sponsor
Neurocrine Biosciences
Phase
Phase 3
Started
2025-04-16
Last updated
2026-07-24

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

NBI-1065845

NBI-1065845: NBI-1065845 tablets

Study summary

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (106)

FacilityCityRegionStatus
Neurocrine Clinical Site Huntsville Alabama Recruiting
Neurocrine Clinical Site Bryant Arkansas Recruiting
Neurocrine Clinical Site Little Rock Arkansas Recruiting
Neurocrine Clinical Site Glendale California Recruiting
Neurocrine Clinical Site Los Angeles California Recruiting
Neurocrine Clinical Site Oceanside California Recruiting
Neurocrine Clinical Site Orange California Recruiting
Neurocrine Clinical Site Pico Rivera California Recruiting
Neurocrine Clinical Site San Diego California Recruiting
Neurocrine Clinical Site San Francisco California Recruiting
Neurocrine Clinical Site San Jose California Recruiting
Neurocrine Clinical Site Upland California Terminated
Neurocrine Clinical Site Cromwell Connecticut Recruiting
Neurocrine Clinical Site Farmington Connecticut Recruiting
Neurocrine Clinical Site Hollywood Florida Recruiting
Neurocrine Clinical Site Maitland Florida Recruiting
Neurocrine Clinical Site Maitland Florida Recruiting
Neurocrine Clinical Site Miami Florida Recruiting
Neurocrine Clinical Site Miami Gardens Florida Recruiting
Neurocrine Clinical Site Orlando Florida Withdrawn
Neurocrine Clinical Site Palm Bay Florida Recruiting
Neurocrine Clinical Site Tampa Florida Recruiting
Neurocrine Clinical Site Tampa Florida Recruiting
Neurocrine Clinical Site Atlanta Georgia Recruiting
Neurocrine Clinical Site Gaithersburg Maryland Recruiting
Neurocrine Clinical Site Boston Massachusetts Recruiting
Neurocrine Clinical Site Watertown Massachusetts Recruiting
Neurocrine Clinical Site O'Fallon Missouri Recruiting
Neurocrine Clinical Site Saint Charles Missouri Recruiting
Neurocrine Clinical Site Cedarhurst New York Recruiting
Neurocrine Clinical Site Mount Kisco New York Recruiting
Neurocrine Clinical Site New York New York Recruiting
Neurocrine Clinical Site New York New York Recruiting
Neurocrine Clinical Site The Bronx New York Recruiting
Neurocrine Clinical Site Avon Lake Ohio Recruiting
Neurocrine Clinical Site Edmond Oklahoma Recruiting
Neurocrine Clinical Site Oklahoma City Oklahoma Withdrawn
Neurocrine Clinical Site Philadelphia Pennsylvania Recruiting
Neurocrine Clinical Site Bellaire Texas Recruiting
Neurocrine Clinical Site Dallas Texas Recruiting

+ 66 more sites — see the full list on the official registry below.

More Neurocrine Biosciences trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06966401 on ClinicalTrials.gov ↗ ← All trials in the USA