Status:
RECRUITING
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety 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 study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
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.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06911112
Start Date
March 31 2025
End Date
July 1 2027
Last Update
December 1 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Neurocrine Clinical Site
Huntsville, Alabama, United States, 35801
2
Neurocrine Clinical Site
Glendale, California, United States, 91206
3
Neurocrine Clinical Site
Irvine, California, United States, 92614
4
Neurocrine Clinical Site
Miami, Florida, United States, 33174