At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- NBI-1065845 (drug), Placebo (drug)
- How long the study runs
- Study runs about 26 months (dates as stated)
- About the drug or intervention
- NBI-1065845 — drug: NBI-1065845 tablets · Placebo — drug: Matching placebo tablets
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a medicine called NBI-1065845 for adults with major depressive disorder (MDD), a condition causing low mood. The medicine is an 'add-on' to the antidepressant tablets people are already taking, because those tablets alone have not helped enough. The study is run by Neurocrine Biosciences and will look at how well the medicine works and how safe it is.
Who can take part
- You have moderate or severe depression that keeps coming back, or a long-term form of depression called persistent depressive disorder.
- Your current antidepressant tablets have not helped enough during this period of depression.
- You have been taking antidepressant tablets for at least 8 weeks and are willing to keep taking the same tablets, at the same dose and as often, for the whole study.
- You score 22 or more on a depression questionnaire called the Hamilton Depression Rating Scale (17 questions) at screening and on day 1 of the study.
- In the study team's view, you are willing and able to follow all the study rules and instructions.
Who may not be able to
- In the past year, you have had another mental health condition that was the main focus of your treatment, other than depression.
- The study team believes you are at immediate risk of suicide, or of harming yourself or other people.
- Your depression has not improved after electroconvulsive therapy (ECT) during this period of depression.
What taking part involves
- • Taking the study medicine NBI-1065845 as an add-on to your usual antidepressant tablets.
- • Continuing your current antidepressant tablets at the same dose and as often as you take them now, for the whole study.
- • How you take the study medicine, and for how long: Not stated — ask the trial team.
Time commitment: Study length and number of visits: Not stated — ask the trial team; taking part means adding the study medicine on top of your usual antidepressant tablets.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2025-05-30
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for major depressive disorder
- • Phase3 - 200 participants
- • The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with major depressive disorder
Where?
- • London - Neurocrine Clinical Site
- • Salford - Neurocrine Clinical Site
- • Sheffield - Neurocrine Clinical Site
- • Southampton - Neurocrine Clinical Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
- ✓Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
- ✓Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- ✓Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
Who cannot take part
- ✗A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other...
- ✗Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
- ✗Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the...
See the full criteria
Where Is This Study? (4 UK sites)
Neurocrine Clinical Site
London SE5 8AZ, United Kingdom
Neurocrine Clinical Site
Salford M6 8HD, United Kingdom
Neurocrine Clinical Site
Sheffield S5 7JT, United Kingdom
Neurocrine Clinical Site
Southampton SO30 3JB, United Kingdom
How to Get in Touch
Neurocrine Medical Information Call Center
Sponsor contactCONTACT