Actively Recruiting
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Led by Neurocrine Biosciences · Updated on 2026-04-23
850
Participants Needed
87
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
CONDITIONS
Official Title
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis of recurrent moderate or severe Major Depressive Disorder or persistent depressive disorder
- Inadequate response to oral antidepressants in current depression episode
- Taking oral antidepressants for at least 8 weeks prior to screening
- Willing and able to comply with all study procedures and restrictions as judged by the investigator
You will not qualify if you...
- Diagnosis of another psychiatric disorder in the last 1 year that was the primary focus of treatment other than Major Depressive Disorder
- Considered by the investigator to be at imminent risk of suicide or harm to self or others
- Other protocol-defined inclusion and exclusion criteria apply
AI-Screening
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Trial Site Locations
Total: 87 locations
1
Neurocrine Clinical Site
Huntsville, Alabama, United States, 35801
Actively Recruiting
2
Neurocrine Clinical Site
Bryant, Arkansas, United States, 72022
Actively Recruiting
3
Neurocrine Clinical Site
Little Rock, Arkansas, United States, 72204
Actively Recruiting
4
Neurocrine Clinical Site
Glendale, California, United States, 91206
Actively Recruiting
5
Neurocrine Clinical Site
Los Angeles, California, United States, 90025
Actively Recruiting
6
Neurocrine Clinical Site
Oceanside, California, United States, 92056
Actively Recruiting
7
Neurocrine Clinical Site
Orange, California, United States, 92866
Actively Recruiting
8
Neurocrine Clinical Site
Pico Rivera, California, United States, 90660
Actively Recruiting
9
Neurocrine Clinical Site
San Diego, California, United States, 92103-8229
Actively Recruiting
10
Neurocrine Clinical Site
Upland, California, United States, 91786
Terminated
11
Neurocrine Clinical Site
Cromwell, Connecticut, United States, 06416
Actively Recruiting
12
Neurocrine Clinical Site
Farmington, Connecticut, United States, 06030
Actively Recruiting
13
Neurocrine Clinical Site
Hollywood, Florida, United States, 33024
Actively Recruiting
14
Neurocrine Clinical Site
Maitland, Florida, United States, 32751-5669
Actively Recruiting
15
Neurocrine Clinical Site
Maitland, Florida, United States, 32751
Actively Recruiting
16
Neurocrine Clinical Site
Miami, Florida, United States, 33174
Actively Recruiting
17
Neurocrine Clinical Site
Miami Gardens, Florida, United States, 33014
Actively Recruiting
18
Neurocrine Clinical Site
Palm Bay, Florida, United States, 32905
Actively Recruiting
19
Neurocrine Clinical Site
Tampa, Florida, United States, 33607
Actively Recruiting
20
Neurocrine Clinical Site
Tampa, Florida, United States, 33629
Actively Recruiting
21
Neurocrine Clinical Site
Atlanta, Georgia, United States, 30318
Actively Recruiting
22
Neurocrine Clinical Site
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
23
Neurocrine Clinical Site
Boston, Massachusetts, United States, 02116
Actively Recruiting
24
Neurocrine Clinical Site
Watertown, Massachusetts, United States, 02472
Actively Recruiting
25
Neurocrine Clinical Site
O'Fallon, Missouri, United States, 63368
Actively Recruiting
26
Neurocrine Clinical Site
Saint Charles, Missouri, United States, 63304
Actively Recruiting
27
Neurocrine Clinical Site
Cedarhurst, New York, United States, 11516
Actively Recruiting
28
Neurocrine Clinical Site
Mount Kisco, New York, United States, 10549
Actively Recruiting
29
Neurocrine Clinical Site
New York, New York, United States, 10029
Actively Recruiting
30
Neurocrine Clinical Site
New York, New York, United States, 10128
Actively Recruiting
31
Neurocrine Clinical Site
The Bronx, New York, United States, 10461
Actively Recruiting
32
Neurocrine Clinical Site
Avon Lake, Ohio, United States, 44012
Actively Recruiting
33
Neurocrine Clinical Site
Edmond, Oklahoma, United States, 73013
Actively Recruiting
34
Neurocrine Clinical Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
35
Neurocrine Clinical Site
Dallas, Texas, United States, 75251
Actively Recruiting
36
Neurocrine Clinical Site
Houston, Texas, United States, 77030
Actively Recruiting
37
Neurocrine Clinical Site
Richmond, Texas, United States, 77407
Withdrawn
38
Neurocrine Clinical Site
Stafford, Texas, United States, 77477
Actively Recruiting
39
Neurocrine Clinical Site
The Woodlands, Texas, United States, 77381
Actively Recruiting
40
Neurocrine Clinical Site
Everett, Washington, United States, 98201
Actively Recruiting
41
Neurocrine Clinical Site
Alken, Belgium, 3570
Actively Recruiting
42
Neurocrine Clinical Site
Mechelen, Belgium, 2800
Actively Recruiting
43
Neurocrine Clinical Site
Plovdiv, Bulgaria, 4400
Actively Recruiting
44
Neurocrine Clinical Site
Sofia, Bulgaria, 1113
Actively Recruiting
45
Neurocrine Clinical Site
Sofia, Bulgaria, 1408
Actively Recruiting
46
Neurocrine Clinical Site
Sofia, Bulgaria, 1510
Actively Recruiting
47
Neurocrine Clinical Site
Sofia, Bulgaria, 1680
Actively Recruiting
48
Neurocrine Clinical Site
Varna, Bulgaria, 9020
Actively Recruiting
49
Neurocrine Clinical Site
Zagreb, Croatia, 10000
Actively Recruiting
50
Neurocrine Clinical Site
Zagreb, Croatia, 10090
Actively Recruiting
51
Neurocrine Clinical Site
Pilsen, Czechia, 30100
Actively Recruiting
52
Neurocrine Clinical Site
Prague, Czechia, 100 00
Actively Recruiting
53
Neurocrine Clinical Site
Prague, Czechia, 11000
Actively Recruiting
54
Neurocrine Clinical Site
Prague, Czechia, 160 00
Actively Recruiting
55
Neurocrine Clinical Site
Prague, Czechia, 186 00
Actively Recruiting
56
Neurocrine Clinical Site
Tallinn, Estonia, 11315
Actively Recruiting
57
Neurocrine Clinical Site
Kuopio, Finland, 70110
Actively Recruiting
58
Neurocrine Clinical Site
Oulu, Finland, 90100
Actively Recruiting
59
Neurocrine Clinical Site
Tampere, Finland, 33210
Actively Recruiting
60
Neurocrine Clinical Site
Budapest, Hungary, 1036
Actively Recruiting
61
Neurocrine
Sigulda, Lativa, Latvia, LV-2150
Actively Recruiting
62
Neurocrine Clinical Site
Jelgava, Latvia, LV-3008
Actively Recruiting
63
Neurocrine Clinical Site
Liepāja, Latvia, LV-3401
Actively Recruiting
64
Neurocrine Clinical Site
Kaunas, Lithuania, LT-44279
Actively Recruiting
65
Neurocrine Clinical Site
Amsterdam, Netherlands, 1081 GN
Not Yet Recruiting
66
Neurocrine Clinical Site
Groningen, Netherlands, 9713 GZ
Not Yet Recruiting
67
Neurocrine Clinical Site
Leiden, Netherlands, 2333 ZA
Not Yet Recruiting
68
Neurocrine Clinical Site
Bełchatów, Poland, 97-400
Actively Recruiting
69
Neurocrine Clinical Site
Bialystok, Poland, 15-404
Actively Recruiting
70
Neurocrine Clinical Site
Bialystok, Poland, 15-756
Actively Recruiting
71
Neurocrine Clinical Site
Bydgoszcz, Poland, 85-794
Actively Recruiting
72
Neurocrine Clinical Site
Gdansk, Poland, 80-283
Actively Recruiting
73
Neurocrine Clinical Site
Gdansk, Poland, 80-546
Actively Recruiting
74
Neurocrine Clinical Site
Grudziądz, Poland, 86-300
Actively Recruiting
75
Neurocrine Clinical Site
Katowice, Poland, 40-514
Actively Recruiting
76
Neurocrine Clinical Site
Craiova, Romania, 200157
Actively Recruiting
77
Neurocrine Clinical Site
Bojnice, Slovakia, 97201
Actively Recruiting
78
Neurocrine Clinical Site
Bratislava, Slovakia, 820 07
Actively Recruiting
79
Neurocrine Clinical Site
Košice, Slovakia, 04001
Actively Recruiting
80
Neurocrine Clinical Site
Rimavská Sobota, Slovakia, 979 01
Actively Recruiting
81
Neurocrine Clinical Site
Svidník, Slovakia, 089 01
Actively Recruiting
82
Neurocrine Clinical Site
Vranov nad Topľou, Slovakia, 093 01
Actively Recruiting
83
Neurocrine Clinical Site
Gothenburg, Sweden, 41345
Actively Recruiting
84
Neurocrine Clinical Site
Lund, Sweden, 222 22
Actively Recruiting
85
Neurocrine Clinical Site
Stockholm, Sweden, 113 29
Actively Recruiting
86
Neurocrine Clinical Site
Sheffield, South Yorkshire, United Kingdom, S3 7ND
Actively Recruiting
87
Neurocrine Clinical Site
London, United Kingdom, SE5 8AF
Actively Recruiting
Research Team
N
Neurocrine Medical Information Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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