Actively Recruiting
Study Evaluating NBI-1065845 Compared to Placebo as Additional Treatment for Major Depressive Disorder
Led by Neurocrine Biosciences · Updated on 2025-10-29
200
Participants Needed
18
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the drug NBI-1065845 compared with a placebo as an additional treatment for adults with Major Depressive Disorder (MDD). This phase 3 study focuses on participants who have moderate to severe recurrent MDD or persistent depressive disorder and who have not adequately responded to oral antidepressant treatments during their current depressive episode. Participants will be randomly assigned to receive either NBI-1065845 tablets or matching placebo tablets alongside their existing oral antidepressants, which they must continue at the same dose and frequency throughout the study. This double-blind, placebo-controlled trial will monitor changes over a period leading up to day 56. During the study, participants' depression symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and on day 56. The study will also monitor safety and adherence to the treatment plan. Researchers aim to measure improvement in depression symptoms as the main outcome of treatment effectiveness.
CONDITIONS
Official Title
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 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 throughout 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 in the opinion of the investigator
You will not qualify if you...
- Diagnosis of any psychiatric disorder in the last year other than Major Depressive Disorder that was the primary focus of treatment
- Considered by the investigator to be at imminent risk of suicide or injury to self or others
- History of nonresponse to electroconvulsive therapy (ECT) during the current major depressive episode
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 18 locations
1
Neurocrine Clinical Site
Little Rock, Arkansas, United States, 72204
Actively Recruiting
2
Neurocrine Clinical Site
Garden Grove, California, United States, 92844
Completed
3
Neurocrine Clinical Site
Orange, California, United States, 92866
Actively Recruiting
4
Neurocrine Clinical Site
Pico Rivera, California, United States, 90660
Actively Recruiting
5
Neurocrine Clinical Site
San Diego, California, United States, 92103
Actively Recruiting
6
Neurocrine Clinical Site
Upland, California, United States, 91786
Actively Recruiting
7
Neurocrine Clinical Site
Hollywood, Florida, United States, 33024
Actively Recruiting
8
Neurocrine Clinical Site
Maitland, Florida, United States, 32751
Actively Recruiting
9
Neurocrine Clinical Site
Boston, Massachusetts, United States, 02116
Actively Recruiting
10
Neurocrine Clinical Site
Watertown, Massachusetts, United States, 02472
Suspended
11
Neurocrine Clinical Site
Mount Kisco, New York, United States, 10549
Actively Recruiting
12
Neurocrine Clinical Site
Avon Lake, Ohio, United States, 44012
Actively Recruiting
13
Neurocrine Clinical Site
Westlake, Ohio, United States, 44145
Completed
14
Neurocrine Clinical Site
Dallas, Texas, United States, 75251
Actively Recruiting
15
Neurocrine Clinical Site
Houston, Texas, United States, 77030
Actively Recruiting
16
Neurocrine Clinical Site
Richmond, Texas, United States, 77407
Withdrawn
17
Neurocrine Clinical Site
The Woodlands, Texas, United States, 77381
Suspended
18
Neurocrine Clinical Site
Everett, Washington, United States, 98201
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
2
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