A Phase 3, Randomized, Double blind, Placebo controlled Study to Evaluate the Effects of Oral NMRA-335140 versus Placebo in Participants with Major Depressive Disorder
This clinical trial is looking at a potential new medicine called NMRA-335140 for people living with major depression. Major depressive disorder causes long-lasting low mood, lack of energy, and loss of interest in daily life. Current treatments do not work for everyone, so scientists are searching for new, effective options. In this study, adults with depression will be given either the new medicine or a dummy pill (placebo) to take by mouth for six weeks. Neither the participants nor the research team will know who receives which tablet during the trial. Doctors will measure changes in mood and the ability to feel pleasure using standard mental health rating questionnaires. The main goal is to confirm whether this tablet is safe and genuinely helps people feel better compared to a dummy pill.
At a glance
What is this study about?
Major depressive disorder is a common mental health condition that goes far beyond simply feeling down or having a bad day. It causes persistent feelings of sadness, emptiness, and fatigue, making it hard to manage work, hobbies, and family life. Many people also struggle with anhedonia, which means losing the ability to feel pleasure or joy from things they usually love. While there are already treatments available, they do not work well for everyone, and finding the right help can be a long and difficult journey.
This clinical trial is testing a new tablet called NMRA-335140 to find out if it can safely improve symptoms of depression. The study focuses heavily on whether the medicine can lift overall low mood and bring back the ability to enjoy everyday activities. To do this, doctors will track participants' progress over six weeks using established mental health check-ins, such as the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Snaith-Hamilton Pleasure Scale (SHAPS).
Because this is a late-stage Phase 3 trial, it is one of the final steps needed to confirm if the drug works before it could potentially be approved for wider NHS or public use. By comparing the new tablet with a dummy pill, researchers can be confident that any improvements seen are truly caused by the medicine itself, helping to advance new treatment options for the future.
Key takeaways
- Tests a new daily tablet (NMRA-335140) for adults with major depressive disorder.
- A Phase 3 study comparing the real medicine against a dummy pill over six weeks.
- Aims to relieve low mood and help people regain the ability to feel pleasure.
- Requires regular clinic visits for health checks and mood questionnaires.
- Participation is entirely voluntary, and you can stop at any time.
Who may be eligible?
This study is open to adults aged 18 and older who are currently experiencing major depressive disorder. Both men and women can apply. Because the trial is testing whether the drug works for active depression, participants need to be having noticeable symptoms at the time they join.
Before you can take part, the trial team will carry out a thorough health check. This includes reviewing your medical history, any other conditions you might have, and any medicines you are currently taking. This is done to make sure it is completely safe for you to take part.
Certain people may not be able to join. For instance, people who have other specific mental health conditions, severe unmanaged physical illnesses, or those who are pregnant or breastfeeding might be excluded for their own safety. The study team will explain all the specific rules in detail before you decide.
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 am currently experiencing symptoms of major depression.
- I am willing to take a daily study tablet for six weeks.
- I can attend regular clinic visits for health checks and questionnaires.
- I am comfortable that I might receive a dummy pill instead of active medicine.
What does participation involve?
Taking part in this study lasts for at least six weeks of active treatment, alongside initial screening and short follow-up checks. You will be randomly chosen to take either the study medicine (NMRA-335140) or an identical dummy pill by mouth each day.
During the trial, you will visit a local clinic regularly so doctors can monitor your health. At these appointments, staff will check your vital signs, take routine blood or urine samples, and ask you detailed questions about your mood and how you are coping. You will also fill out standard questionnaires that look at your depressive symptoms and your ability to enjoy life.
After you finish the six-week treatment period, the study team will continue to check in on you for a short time to ensure you remain well and to see if you have any lingering side effects.
Potential risks and benefits
Locations (7)
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedFinland
- —UnverifiedSweden
- —UnverifiedPoland
Common questions
What is a placebo and why is it used?
A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. It helps researchers prove whether any improvements are truly caused by the study drug.
Will I know if I am taking the real medicine?
No. This is a 'double-blind' trial, which means neither you nor the study doctors will know who is taking the active drug or the dummy pill until the study finishes.
Will taking part cost me anything?
No, the study medicine and all tests are provided free of charge. Most trials also help cover travel expenses for clinic visits.
Can I leave the study early if I change my mind?
Yes. You have the right to withdraw at any time, for any reason, and your regular medical care will not be affected in any way.
What happens if my mood gets worse during the trial?
The medical team monitors you closely throughout the trial. If your mental health declines or you feel unsafe, they can stop the study treatment immediately and arrange appropriate support.
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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