Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06966401

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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