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)
- How long the study runs
- Study runs about 61 months (dates as stated)
- About the drug or intervention
- NBI-1065845 — drug: NBI-1065845 tablets
- Patient visit burden
- Not specified by the sponsor
In plain English
This long-term study is looking at the safety and tolerability of a medicine called NBI-1065845 in people with major depressive disorder (MDD), a condition involving long-lasting low mood. The medicine is being tested as an add-on treatment, which means it is taken alongside a person's usual antidepressant tablets. The study is funded by Neurocrine Biosciences.
Who can take part
- You have a main diagnosis of recurring moderate or severe major depressive disorder (MDD), or persistent depressive disorder.
- Your current antidepressant tablets have not helped you enough.
- You have been taking antidepressant tablets for at least 8 weeks before joining the study.
- You are willing and able to follow all the study rules and procedures.
Who may not be able to
- You have been treated mainly for another mental health condition in the past year, rather than MDD.
- The study team believes you are at immediate risk of suicide or of harming yourself or others.
- Other study rules may also apply — ask the trial team.
What taking part involves
- • Taking NBI-1065845 as an add-on to your existing oral antidepressant treatment.
- • Not stated — ask the trial team.
Time commitment: The data does not state how long the study lasts or what taking part involves — ask the trial team.
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
- 850
- Started
- 2025-04-16
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for major depressive disorder
- • Phase3 - 850 participants
- • This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with major depressive disorder
Where?
- • Southampton - Neurocrine Clinical Site
- • Sheffield - Neurocrine Clinical Site
- • London - Neurocrine Clinical Site
- • Manchester - Neurocrine Clinical Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
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
Treatment history
Treatments you must have had:
- ✓ been taking oral antidepressants for at least 8 weeks
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.
- ✓Participant must have been taking oral antidepressants for at least 8 weeks prior to screening.
- ✓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.
- ✗Other protocol defined inclusion and exclusion criteria apply.
See the full criteria
Where Is This Study? (4 UK sites)
Neurocrine Clinical Site
Southampton SO30 3JB, United Kingdom
Neurocrine Clinical Site
Sheffield S3 7ND, United Kingdom
Neurocrine Clinical Site
London SE5 8AF, United Kingdom
Neurocrine Clinical Site
Manchester M25 3BL, United Kingdom
How to Get in Touch
Neurocrine Medical Information Call Center
Sponsor contactCONTACT