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)
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Neurocrine Clinical Site
RECRUITING
Little Rock
California
Neurocrine Clinical Site
RECRUITING
Orange
Neurocrine Clinical Site
RECRUITING
Pico Rivera
Neurocrine Clinical Site
RECRUITING
Upland
Florida
Neurocrine Clinical Site
RECRUITING
Hollywood
Neurocrine Clinical Site
RECRUITING
Maitland
Neurocrine Clinical Site
RECRUITING
Tampa
Georgia
Neurocrine Clinical Site
RECRUITING
Atlanta
Massachusetts
Neurocrine Clinical Site
RECRUITING
Boston
Neurocrine Clinical Site
RECRUITING
Watertown
Missouri
Neurocrine Clinical Site
RECRUITING
Saint Charles
New York
Neurocrine Clinical Site
RECRUITING
Mount Kisco
Neurocrine Clinical Site
RECRUITING
The Bronx
Ohio
Neurocrine Clinical Site
RECRUITING
Avon Lake
Texas
Neurocrine Clinical Site
RECRUITING
Dallas
Neurocrine Clinical Site
RECRUITING
Richmond
Neurocrine Clinical Site
RECRUITING
The Woodlands
Washington
Neurocrine Clinical Site
RECRUITING
Everett
Contact Information
Primary
Neurocrine Medical Information Call Center
medinfo@neurocrine.com
1-877-641-3461
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2030-05
Participants
Target number of participants: 600
Treatments
Experimental: NBI-1065845
NBI-1065845 administered orally once a day.
Related Therapeutic Areas
Sponsors
Leads: Neurocrine Biosciences