Status:
RECRUITING
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
April 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06966401
Start Date
April 16 2025
End Date
May 1 2030
Last Update
August 1 2025
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Neurocrine Clinical Site
Little Rock, Arkansas, United States, 72204
2
Neurocrine Clinical Site
Orange, California, United States, 92866
3
Neurocrine Clinical Site
Pico Rivera, California, United States, 90660
4
Neurocrine Clinical Site
Upland, California, United States, 91786