RecruitingPHASE3INTERVENTIONAL

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

This research study is for adults diagnosed with major depressive disorder (often called depression) who haven't fully improved with their current antidepressant medicine. It's testing a new medicine, NBI-1065845, which would be taken in addition to their usual antidepressant. The main focus is to understand if this new medicine is safe to use over a longer period and how well people tolerate it. By finding medicines that work better, researchers hope to offer more options for people living with depression. This is an important step in developing new treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Neurocrine Biosciences

Enrolment target

850

Start

16 Apr 2025

Estimated completion

01 May 2030

Major Depressive Disorder

What is this study about?

This study is exploring a new medicine called NBI-1065845 for adults who are experiencing major depressive disorder, often simply called depression. If you've been diagnosed with depression and your current antidepressant medicine hasn't fully helped you feel better, this study might be for you. The new medicine is designed to be taken *alongside* your regular antidepressant, not instead of it. Think of it as an extra help.

The main purpose of this particular study is to check the long-term safety of NBI-1065845. This means researchers want to see if there are any side effects that appear over a longer period of time and if people find the medicine easy to take. It's a 'Phase 3' study, which means it's one of the final steps before a new medicine might be considered for wider use.

Finding new and effective treatments for depression is very important because many people struggle to find a medicine that works well for them. By taking part in studies like this, volunteers help doctors learn more about potential new options that could improve the lives of many people in the future.

Key takeaways

This study is for adults with depression whose current treatment isn't quite enough.
It tests a new medicine (NBI-1065845) to be taken alongside regular antidepressants.
The main aim is to check its long-term safety and how well people tolerate it.
Participation involves regular clinic visits, health checks, and taking the study medicine.
You can stop participating at any time.
Your involvement helps advance potential new treatments for depression.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have a diagnosis of depression that keeps coming back, or a long-lasting type of depression. A key requirement is that your current antidepressant medicine hasn't completely helped your depression, and you've been taking it regularly for at least eight weeks before thinking about joining the study.

There are also some important reasons why you might not be able to join. For example, if you've had other serious mental health conditions in the last year that were the main focus of your treatment, or if the doctors feel you are at immediate risk of harming yourself or others, you wouldn't be able to participate. The study team will review your full medical history carefully to make sure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of depression (MDD) that often returns, or is long-lasting?
Has your current antidepressant medicine not fully helped you feel better?
Have you been taking your current antidepressant regularly for at least 8 weeks?
Have you NOT had another major mental health condition that needed treatment in the last year (other than depression)?
Are you able and willing to attend regular study appointments and follow instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, NBI-1065845, in addition to your current antidepressant. You would have regular visits to the study clinic where doctors and nurses would monitor your health, check for any side effects, and see how you are feeling. These visits might include physical examinations, blood tests, and questionnaires about your mood and well-being. The total length of your participation in the study, including how many visits and for how long, will be fully explained to you by the study team.

Potential risks and benefits

Taking part in a study like this could potentially offer you access to a new medicine that isn't widely available yet, which might help your depression if current treatments aren't fully working. However, as with all medicines, there's always a chance of side effects, and the new medicine might not work for everyone. The study team will explain all known potential risks and benefits in detail before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (87)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Neurocrine Clinical Site
Verified postcode
Huntsville, United States· Recruiting
Neurocrine Clinical Site
Verified postcode
Bryant, United States· Recruiting
Neurocrine Clinical Site
Verified postcode
Little Rock, United States· Recruiting
Neurocrine Clinical Site
Verified postcode
Glendale, United States· Recruiting
Neurocrine Clinical Site
Verified postcode
Los Angeles, United States· Recruiting
Neurocrine Clinical Site
Verified postcode
Oceanside, United States· Recruiting
Neurocrine Clinical Site
Verified postcode
Orange, United States· Recruiting
Neurocrine Clinical Site
Verified postcode
Pico Rivera, United States· Recruiting
Neurocrine Clinical Site
Verified postcode
San Diego, United States· Recruiting
Neurocrine Clinical Site
Verified postcode
Upland, United States· Terminated
Neurocrine Clinical Site
Verified postcode
Cromwell, United States· Recruiting
Neurocrine Clinical Site
Verified postcode
Farmington, United States· Recruiting

Common questions

What is 'Major Depressive Disorder (MDD)'?

MDD is a serious mental health condition where you may have persistent feelings of sadness, loss of interest, and other symptoms that affect your daily life for a long time.

What does 'adjunctive treatment' mean?

It means the new medicine, NBI-1065845, would be taken *in addition to* your current antidepressant medicine, not as a replacement.

Why is this study needed?

It helps researchers find out if new medicines are safe and effective for people with depression who struggle to find relief with existing treatments.

What is a 'Phase 3' study?

This is a later stage of research where a new medicine is tested on a larger group of people to confirm its safety and effectiveness before it can be considered for approval.

Will I know if I'm getting the new medicine?

In some studies, you might not know if you're getting the active medicine or a dummy pill (placebo) to ensure fair results. The study team will explain how this particular study works.

How to find out more

Neurocrine Medical Information Call Center

medinfo@neurocrine.com 1-877-641-3461 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.