Long-term Study to Assess the Safety and Effectiveness of NMRA-335140 in Participants with Major Depressive Disorder
Major depressive disorder is a serious mental health condition that causes persistent feelings of sadness, low energy, and a loss of enjoyment in everyday activities. While treatments are available, they do not work for everyone, and new options are needed. This Phase 3 study is researching a new medicine called NMRA-335140 for adults aged 18 and over. Researchers want to understand both the long-term safety of the medicine and how well it helps relieve depression symptoms. Throughout the study, doctors will keep a close eye on participants' health. They will perform routine medical checks, heart traces, blood tests, and eye exams. Participants will also complete regular questionnaires about their mood, anxiety, daily activities, and general wellbeing. Taking part is entirely voluntary, and participants help researchers find out if this could be an effective future treatment.
At a glance
What is this study about?
Major depressive disorder is much more than simply feeling down. It is a lasting illness that can affect every part of life, making it hard to work, socialise, or find pleasure in everyday hobbies. Many people struggle to find an antidepressant that works well for them without causing unwanted side effects. Because of this, scientists are constantly searching for new, more effective treatments.
This research study focuses on an investigational medicine called NMRA-335140. It is a 'Phase 3' study, which means the drug has already shown promise in earlier, smaller trials. Researchers now want to confirm how well it works across a broader group of people and ensure it remains safe to use over a longer period.
As well as tracking overall mood, the study will look closely at specific aspects of mental health that are often missed. These include 'anhedonia' (the loss of the ability to feel pleasure), feelings of anxiety, and sexual wellbeing. The study also monitors how much the treatment helps people carry out their normal daily routines at home and work.
By taking part, participants provide vital information about how the body handles the medicine over time. This helps doctors understand whether NMRA-335140 could become a reliable new prescription option for people living with depression in the future.
Key takeaways
- The study evaluates a new medicine (NMRA-335140) for major depression.
- Open to adults aged 18 and older with diagnosed depression.
- Aims to confirm long-term safety and check if it relieves mood and anxiety symptoms.
- Involves regular clinic visits, health tests, eye exams, and mood questionnaires.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older of any sex who have been diagnosed with major depressive disorder. Doctors are looking for people whose depression is currently causing notable symptoms that interfere with their day-to-day life.
To join, participants must be willing and able to attend regular clinic visits, take the study medication as instructed, and complete regular health questionnaires. Because safety is the top priority, people with certain other physical or mental health conditions, or those taking specific medications that could clash with the study drug, may not be able to take part.
A trial doctor will review your full medical history and carry out some basic health checks to make sure taking part is safe and appropriate for you.
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.
- I am aged 18 or older.
- I have been diagnosed with major depressive disorder (clinical depression).
- I am currently experiencing symptoms of depression.
- I can attend regular clinic appointments for check-ups and tests.
- I am willing to take the study medicine and answer questions about my mood and health.
What does participation involve?
If you take part, you will be asked to take the study medicine as directed by the clinic team. You will have regular appointments at the trial clinic so doctors can closely follow your health and progress. These visits will include standard physical examinations, blood pressure and pulse checks, blood and urine tests, and heart traces (ECGs). You will also have specialised eye checks to monitor your eye health during the study. At each visit, you will fill in questionnaires about your mood, anxiety levels, sexual health, and how well you are managing daily tasks. The trial team will support you throughout the study and explain exactly how long your treatment and follow-up period will last.
Potential risks and benefits
Locations (7)
- —UnverifiedBulgaria
- —UnverifiedCzechia
- —UnverifiedSweden
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedFinland
- —UnverifiedFrance
Common questions
What does a Phase 3 trial mean?
A Phase 3 trial tests a new treatment in a larger group of people to confirm how well it works and check for side effects before it can be approved for general use.
Will I have to pay to take part?
No, you do not pay for the study medicine, clinic visits, or tests. Travel expenses to and from the clinic are often reimbursed.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason. Your regular doctor will continue to support your care as normal.
Why are there eye exams in a depression study?
Safety is closely monitored in clinical trials. Detailed eye checks are used to ensure the study medicine has no hidden effects on your eyesight or the surface of your eyes.
Can I stay on my current depression tablets?
It depends on the trial rules. Some studies require you to switch medicines, while others allow certain ongoing treatments. The trial doctor will explain what is needed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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