A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia
This research study is about finding better ways to prevent depression from returning. Specifically, it's for people with major depression who also struggle to feel pleasure, a common symptom called anhedonia. The study is testing a new medication, JNJ-67953964, alongside their usual antidepressant. Some participants will receive the new medication, and others will receive a placebo (a dummy pill that looks the same but has no active drug). This helps researchers understand if the new medication truly helps prevent depression from coming back. It’s a crucial step to see if this treatment can offer a new option for long-term well-being.
At a glance
What is this study about?
This study is designed to explore a new potential treatment for people living with depression. We know that depression can be a really tough condition, and sometimes it comes back even after treatment. A common and difficult part of depression for many people is something called anhedonia. This means having a hard time feeling pleasure or interest in things they used to enjoy, like hobbies, food, or spending time with loved ones. This study focuses on people who experience both major depression and this moderate-to-severe feeling of anhedonia.
The main goal of this research is to see if a new medication called JNJ-67953964 can help prevent these depressive episodes, especially the anhedonia, from coming back. Participants will continue to take their existing antidepressant medication and will also receive either the study drug or a placebo. A placebo is a pill that looks exactly like the study drug but contains no active ingredients. This is a standard and important part of medical research, as it helps doctors accurately tell if a new medicine is actually working or if improvements are due to other factors.
By comparing the new drug to a placebo, researchers can get a clear picture of whether JNJ-67953964 helps people stay well for longer, reducing the chances of their depression, particularly the anhedonia, returning. This type of study is called a "Phase III" trial, which means it’s one of the final steps in testing a new medicine before it might become widely available.
Key takeaways
- This study is testing a new medication (JNJ-67953964) to prevent depression from returning.
- It's for adults with major depression and moderate-to-severe anhedonia (difficulty feeling pleasure).
- Participants will also continue their current antidepressant medication.
- Individuals will receive either the new drug or a placebo (dummy pill).
- The study aims to see if JNJ-67953964 can help people stay well for longer.
- Regular check-ups and monitoring will be part of taking part.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. Both men and women are welcome to participate. The study is specifically for individuals who have been diagnosed with major depressive disorder.
Crucially, you would also need to be experiencing moderate to severe anhedonia, which means you have a significant struggle with feeling pleasure or interest in daily activities. This study is looking for people who are already taking an antidepressant medication as part of their current treatment plan.
- Are you 18 years old or older?
- Have you been diagnosed with major depressive disorder?
- Do you experience moderate to severe difficulty feeling pleasure or interest?
- Are you currently taking an antidepressant medication?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would first go through a screening process to make sure the study is right for you. If eligible, you would then be assigned to receive either the new study medication (JNJ-67953964) or a matching placebo tablet, in addition to your current antidepressant. Neither you nor your study doctor would know which one you are receiving – this is called 'double-blind' and helps ensure the results are fair.
The main part of the study involves regular visits to the clinic, where you'll have check-ups, answer questions about how you're feeling, and discuss any side effects. You'll continue to take the assigned study treatment for a period to see how it affects your risk of depression returning. The study staff will monitor your health closely throughout this time. The total duration of your participation, including all visits and follow-ups, will be explained in detail by the study team.
Potential risks and benefits
Locations (9)
- —Bulgaria
- —Greece
- —Spain
- —Czechia
- —France
- —Romania
- —Poland
- —Germany
- —Belgium
Common questions
What is anhedonia?
Anhedonia is when you have difficulty feeling pleasure or interest in things that you used to enjoy, like hobbies, food, or spending time with friends and family.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It's used in studies to help researchers see if the actual medicine is truly effective.
Will I still take my regular antidepressant?
Yes, this study involves taking either the new study medication or a placebo *in addition* to your current antidepressant medication.
What is a 'Phase III' study?
A Phase III study is a later stage of research. It means the new medication has already been tested for safety in earlier phases and is now being widely tested to confirm its effectiveness and monitor side effects.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care or relationship with your doctor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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