Actively 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)
Led by Neurocrine Biosciences · Updated on 2025-12-01
200
Participants Needed
10
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 6522 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Neurocrine Clinical Site
Huntsville, Alabama, United States, 35801
Actively Recruiting
2
Neurocrine Clinical Site
Glendale, California, United States, 91206
Actively Recruiting
3
Neurocrine Clinical Site
Irvine, California, United States, 92614
Actively Recruiting
4
Neurocrine Clinical Site
Miami, Florida, United States, 33174
Actively Recruiting
5
Neurocrine Clinical Site
Tampa, Florida, United States, 33607
Actively Recruiting
6
Neurocrine Clinical Site
Atlanta, Georgia, United States, 30318
Actively Recruiting
7
Neurocrine Clinical Site
Boston, Massachusetts, United States, 02131
Actively Recruiting
8
Neurocrine Clinical Site
Saint Charles, Missouri, United States, 63304
Actively Recruiting
9
Neurocrine Clinical Site
The Bronx, New York, United States, 10461
Actively Recruiting
10
Neurocrine Clinical Site
Mason, Ohio, United States, 45040
Actively Recruiting
Research Team
N
Neurocrine Medical Information Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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