Status:
RECRUITING
A Study to Evaluate the Maintenance Effect 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
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 pa...
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 and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
- Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- 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.
- Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
- Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Key Trial Info
Start Date :
August 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT07196501
Start Date
August 18 2025
End Date
July 1 2028
Last Update
September 29 2025
Active Locations (4)
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1
Neurocrine Clinical Site
Melbourne, Florida, United States, 32901
2
Neurocrine Clinical Site
Miami Gardens, Florida, United States, 33014
3
Neurocrine Clinical Site
O'Fallon, Missouri, United States, 63368
4
Neurocrine Clinical Site
Friendswood, Texas, United States, 77546