Actively Recruiting
NBI-1065845-MDD3026: 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 2026-04-15
200
Participants Needed
30
Research Sites
108 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-MDD3026: 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 Major Depressive Disorder (moderate or severe) or persistent depressive disorder.
- Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
- Participant has been taking oral antidepressants for at least 8 weeks and agrees to continue the same dose and frequency throughout the study.
- Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score of 22 or higher at screening and baseline (Day 1).
- Willing and able to follow all study procedures and restrictions as judged by the investigator.
You will not qualify if you...
- Diagnosis of any psychiatric disorder other than MDD that was the primary focus of treatment within the past year.
- Considered by the investigator to be at imminent risk of suicide or harm to self or others.
- History of nonresponse to electroconvulsive therapy (ECT) during the current major depressive episode.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Neurocrine Clinical Site
Chino, California, United States, 91710
Actively Recruiting
2
Neurocrine Clinical Site
Los Angeles, California, United States, 90025
Actively Recruiting
3
Neurocrine Clinical Site
Stanford, California, United States, 94305
Actively Recruiting
4
Neurocrine Clinical Site
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Neurocrine Clinical Site
Cromwell, Connecticut, United States, 06416
Active, Not Recruiting
6
Neurocrine Clinical Site
Farmington, Connecticut, United States, 06030
Active, Not Recruiting
7
Neurocrine Clinical Site
Maitland, Florida, United States, 32751
Actively Recruiting
8
Neurocrine Clinical Site
Miami, Florida, United States, 33136
Actively Recruiting
9
Neurocrine Clinical Site
Tampa, Florida, United States, 33613
Withdrawn
10
Neurocrine Clinical Site
Gaithersburg, Maryland, United States, 20877
Active, Not Recruiting
11
Neurocrine Clinical Site
Cedarhurst, New York, United States, 11516
Actively Recruiting
12
Neurocrine Clinical Site
New York, New York, United States, 10029
Active, Not Recruiting
13
Neurocrine Clinical Site
New York, New York, United States, 10128
Actively Recruiting
14
Neurocrine Clinical Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
Neurocrine Clinical Site
Alken, Belgium, 3570
Active, Not Recruiting
16
Neurocrine Clinical Site
Bruges, Belgium, 8310
Actively Recruiting
17
Neurocrine Clinical Site
Mechelen, Belgium, 2800
Actively Recruiting
18
Neurocrine Clinical Site
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
19
Neurocrine Clinical Site
Kuopio, Finland, 70110
Actively Recruiting
20
Neurocrine Clinical Site
Oulu, Finland, 90100
Actively Recruiting
21
Neurocrine Clinical Site
Tampere, Finland, 33210
Actively Recruiting
22
Neurocrine Clinical Site
Budapest, Hungary, 1036
Actively Recruiting
23
Neurocrine Clinical Site
Budapest, Hungary, 1083
Actively Recruiting
24
Neurocrine Clinical Site
Gyöngyös, Hungary, 3200
Actively Recruiting
25
Neurocrine Clinical Site
Jelgava, Latvia, LV-3008
Actively Recruiting
26
Neurocrine Clinical Site
Liepāja, Latvia, LV-3401
Actively Recruiting
27
Neurocrine Clinical Site
Sigulda, Latvia, LV-2150
Actively Recruiting
28
Neurocrine Clinical Site
Manchester, United Kingdom, M8 5RB
Actively Recruiting
29
Neurocrine Clinical Site
Sheffield, United Kingdom, S5 7JT
Actively Recruiting
30
Neurocrine Clinical Site
Southampton, United Kingdom, SO30 3JB
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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