What is NBI-1065845 studying for Major Depressive Disorder?

NBI-1065845 is being studied as an additional treatment for people with major depressive disorder who have not responded well to oral antidepressants. The study aims to evaluate whether NBI-1065845 can improve symptoms of depression. Neurocrine Biosciences is sponsoring this research to better understand this treatment option.

Who may be eligible for this Major Depressive Disorder clinical trial?

Adults aged 18 years and older diagnosed with recurrent or persistent major depressive disorder who have not responded well to oral antidepressants may be eligible. Participants must have been on antidepressants for at least 8 weeks and willing to continue. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this Major Depressive Disorder clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06963021

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder MDD

Led by Neurocrine Biosciences · Updated on 2026-04-15

200

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of NBI-1065845 as an additional treatment in people with Major Depressive Disorder MDD, specifically those with moderate to severe depression or persistent depressive disorder who have not responded well to oral antidepressants. This Phase 3 study compares NBI-1065845 to a placebo to see if it improves symptoms of depression, focusing on reducing depression severity. Participants will receive either NBI-1065845 tablets or placebo tablets that look the same, taken orally once a day. They must continue their current oral antidepressant treatments at the same dose and frequency throughout the study. The study uses a randomized, double-blind, placebo-controlled design to fairly assess the effects of the treatments. During participation, individuals will be assessed at the start and after 56 days using measures such as the Montgomery-sberg Depression Rating Scale to track depression symptoms, the Sheehan Disability Scale to evaluate functional disability, and the Clinical Global Impression-Severity Scale. Researchers will monitor safety and treatment adherence while participants follow all study procedures. The study is expected to continue until July 2027.

CONDITIONS

Brief 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

Age: 18Years +

All Genders

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 and agree to continue 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 per investigator judgment.

You will not qualify if you...

Diagnosis of any other psychiatric disorder in the last year that was the primary focus of treatment besides major depressive disorder.
Considered by the investigator to be at imminent risk of suicide or harm to self or others.
Previous nonresponse to electroconvulsive therapy (ECT) during the current major depressive episode.

Research Team

Neurocrine Medical Information Call Center

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