Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder
Led by Neurocrine Biosciences · Updated on 2026-03-19
550
Participants Needed
45
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of NBI-1065845 as an additional treatment to delay the return of depressive symptoms in adults with major depressive disorder (MDD). This Phase 3 study compares NBI-1065845 with a placebo to understand its ability to maintain symptom relief in participants who have had an inadequate response to oral antidepressants. The study is led by Neurocrine Biosciences and uses a randomized, double-blind, placebo-controlled design. Participants will first receive NBI-1065845 during an open-label treatment period. Then, they will be randomly assigned to continue either NBI-1065845 or switch to a matching placebo during a double-blind maintenance phase. The treatments are given as oral tablets, and participants will continue their existing oral antidepressants at the same dose throughout the study. Participants will be monitored from randomization to the earliest relapse or the end of the study, which can last up to about 32 months. Researchers will assess the time until depressive symptoms return using the Hamilton Depression Rating Scale. Safety and adherence to study procedures will be regularly checked to ensure participant well-being during the trial.
CONDITIONS
Brief Title
A Study to Evaluate the Maintenance Effect 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.
- Participant must have been taking oral antidepressants for at least 8 weeks.
- Participant is willing to continue the same oral antidepressants at the same dose and frequency during the study.
- Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score of 22 or higher at screening and baseline.
- Willing and able to comply with all study procedures and restrictions as judged by the investigator.
You will not qualify if you...
- Diagnosis of any other psychiatric disorder in the last year as the primary focus of treatment, other than major depressive disorder.
- Considered to be at imminent risk of suicide or injury to self or others.
- Depressive symptoms have previously shown nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
- Other protocol-defined inclusion and exclusion criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration not specified
Participants receive NBI-1065845 as an adjunctive treatment during the open-label phase.
Visit schedule not specified
Duration - Up to approximately 32 months
Participants are randomized to receive either NBI-1065845 or placebo as adjunctive treatment to evaluate maintenance effect.
Visit schedule not specified
Trial Site Locations
Total: 45 locations
1
Neurocrine Clinical Site
Oceanside, California, United States, 92056
Actively Recruiting
2
Neurocrine Clinical Site
San Jose, California, United States, 95124
Actively Recruiting
3
Neurocrine Clinical Site
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
Neurocrine Clinical Site
Miami Gardens, Florida, United States, 33014
Actively Recruiting
5
Neurocrine Clinical Site
Orlando, Florida, United States, 32803
Actively Recruiting
6
Neurocrine Clinical Site
Palm Bay, Florida, United States, 32905
Actively Recruiting
7
Neurocrine Clinical Site
Tampa, Florida, United States, 33629
Actively Recruiting
8
Neurocrine Clinical Site
Marrero, Louisiana, United States, 70072
Actively Recruiting
9
Neurocrine Clinical Site
O'Fallon, Missouri, United States, 63368
Actively Recruiting
10
Neurocrine Clinical Site
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
11
Neurocrine Clinical Site
Charlotte, North Carolina, United States, 28211
Actively Recruiting
12
Neurocrine Clinical Site
Edmond, Oklahoma, United States, 73013
Actively Recruiting
13
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
14
Neurocrine Clinical Site
Bellaire, Texas, United States, 77401
Actively Recruiting
15
Neurocrine Clinical Site
Friendswood, Texas, United States, 77546
Actively Recruiting
16
Neurocrine Clinical Site
Stafford, Texas, United States, 77477
Actively Recruiting
17
Neurocrine Clinical Site
Wichita Falls, Texas, United States, 76309
Actively Recruiting
18
Neurocrine Clinical Site
Draper, Utah, United States, 84020
Actively Recruiting
19
Neurocrine Clinical Site
Carlton, Victoria, Australia, 3053
Actively Recruiting
20
Neurocrine Clinical Site
Sofia, Bulgaria, 1303
Actively Recruiting
21
Neurocrine Clinical Site
Sofia, Bulgaria, 1408
Actively Recruiting
22
Neurocrine Clinical Site
Sofia, Bulgaria, 1510
Actively Recruiting
23
Neurocrine Clinical Site
Sofia, Bulgaria, 1680
Actively Recruiting
24
Neurocrine Clinical Site
North Vancouver, British Columbia, Canada, V7P 2T4
Actively Recruiting
25
Neurocrine Clinical Site
Sherbrooke, Quebec, Canada, J1L 0H8
Actively Recruiting
26
Neurocrine Clinical Site
Toronto, Canada, M5H 1A1
Actively Recruiting
27
Neurocrine Clinical Site
Tallinn, Estonia, 10138
Actively Recruiting
28
Neurocrine Clinical Site
Tallinn, Estonia, 11315
Actively Recruiting
29
Neurocrine Clinical Site
Tartu, Estonia, 50417
Actively Recruiting
30
Neurocrine Clinical Site
Milan, Italy, 20127
Actively Recruiting
31
Neurocrine Clinical Site
Rome, Italy, 168
Actively Recruiting
32
Neurocrine Clinical Site
Bialystok, Poland, 15-879
Actively Recruiting
33
Neurocrine Clinical Site
Bydgoszcz, Poland, 85-794
Actively Recruiting
34
Neurocrine Clinical Site
Gdansk, Poland, 80-283
Actively Recruiting
35
Neurocrine Clinical Site
Belgrade, Serbia, 11000
Actively Recruiting
36
Neurocrine Clinical Site
Kovin, Serbia, 26220
Actively Recruiting
37
Neurocrine Clinical Site
Ansan-si, Gyeonggi-do, South Korea, 15355
Actively Recruiting
38
Neurocrine Clinical Site
Seoul, South Korea, 02841
Actively Recruiting
39
Neurocrine Clinical Site
Seoul, South Korea, 06351
Actively Recruiting
40
Neurocrine Clinical Site
Alcorcón, Madrid, Spain, 28922
Actively Recruiting
41
Neurocrine Clinical Site
Barcelona, Spain, 08035
Actively Recruiting
42
Neurocrine Clinical Site
Keelung, Taiwan, 204
Actively Recruiting
43
Neurocrine Clinical Site
Taipei, Taiwan, 10449
Actively Recruiting
44
Neurocrine Clinical Site
Taipei, Taiwan, 110
Actively Recruiting
45
Neurocrine Clinical Site
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
N
Neurocrine Medical Information Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here