A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and an Open-label Long-term Extension Treatment with Aticaprant
This research study is for adults over 18 who have major depression and haven't found enough relief from their current antidepressant medication, especially if they have moderate to severe anhedonia (a reduced ability to feel pleasure). The study is testing a new medication called Aticaprant (also known as JNJ-67953964) to see if adding it to their current treatment helps. Half of the participants will receive Aticaprant, and the other half will receive a dummy pill (placebo), without knowing which one they're getting. The main goal is to measure changes in depression symptoms over about six weeks. After this, participants may have the option to continue taking Aticaprant in an extended study. This is a Phase 3 study, meaning it's a large, important trial to confirm the treatment's effects.
At a glance
What is this study about?
This study is called a 'randomized, double-blind, multicenter, placebo-controlled study.' Let's break down what that means in simple terms.
'Randomized' means that participants will be assigned by chance, like flipping a coin, to one of two groups: one group will receive the new study medication, Aticaprant, and the other group will receive a 'placebo' which looks identical but contains no active medicine. 'Double-blind' means neither you nor your study doctor will know which treatment you are receiving until the study is over. This helps ensure that everyone involved is unbiased when checking to see if the medication is working. 'Multicenter' simply means that this same study is happening at many different hospitals or clinics in various locations, which helps gather a lot of information.
The main purpose of this study is to find out if Aticaprant, when added to your current antidepressant, can help improve symptoms of depression, particularly if you experience moderate to severe "anhedonia," which is a medical term for a significant loss of interest or pleasure in things you once enjoyed. Many people with depression experience this, and it can be very challenging. The study is also looking at how safe Aticaprant is and how well people tolerate it. This is considered a 'Phase 3' study, which means it's one of the final steps in testing a new medication before it might be considered for wider medical use. This type of study typically involves a large number of participants to confirm the results seen in earlier, smaller studies. This research is important because it could lead to new treatment options for people living with depression who haven't yet found enough relief.
Key takeaways
- This study is for adults with depression and significant loss of pleasure, whose current treatment isn't enough.
- It tests a new medication called Aticaprant, taken alongside existing antidepressants.
- Participants will either receive Aticaprant or an inactive placebo.
- The study aims to see if Aticaprant improves depression symptoms and anhedonia.
- It's a 'Phase 3' study, meaning it's a key step in testing a new treatment.
Who may be eligible?
This study is looking for adult volunteers, aged 18 years or older, who have been diagnosed with major depressive disorder. It's specifically for those who are currently taking an antidepressant medication but still feel that their depression is not well-controlled, especially if they struggle with a significant loss of pleasure or interest in daily activities (this is sometimes called moderate to severe anhedonia).
To be considered for this study, you would need to be in general good health apart from your depression and meet specific criteria set by the study doctors. These criteria ensure that the study is as safe as possible for all participants and that the results are clear and reliable. For example, certain other medical conditions or medications might mean you can't join the study.
Both men and women are welcome to participate. If you're interested, the study team will ask you some detailed questions and perform some health checks to make sure this study is the right fit 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.
- Are you 18 years old or older?
- Have you been diagnosed with major depression?
- Are you currently taking an antidepressant, and it's not working as well as you'd like?
- Do you often feel a significant lack of pleasure or interest in things you used to enjoy?
- Are you willing to attend regular clinic visits?
What does participation involve?
If you decide to take part in this study, you would be assigned to either receive the new medication, Aticaprant, or a placebo (a dummy pill). You would take this study medication while continuing your current antidepressant as prescribed by your doctor. The study involves regular visits to the clinic, where you would have health checks, blood tests, and answer questionnaires about your mood and how you are feeling. These assessments help the study team understand how the medication is affecting your symptoms and if you are experiencing any side effects.
The initial part of the study where you receive either Aticaprant or placebo would last for about six weeks. After this controlled phase, if determined appropriate by the study team, you may have the option to enter an "open-label long-term extension." This means everyone in this extension part would receive Aticaprant, and you would be monitored for a longer period to see the long-term effects and safety. The overall duration of your participation would depend on whether you join the extension and how long that part of the study runs. Throughout the entire process, you would have medical supervision and support from the study team.
Potential risks and benefits
Locations (8)
- —UnverifiedBelgium
- —UnverifiedBulgaria
- —UnverifiedPoland
- —UnverifiedSweden
- —UnverifiedHungary
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedFinland
Common questions
What is anhedonia?
Anhedonia means having a reduced ability to feel pleasure or find interest in activities you used to enjoy, which is a common symptom of depression.
What is a placebo?
A placebo is a 'dummy pill' that looks exactly like the study medication but contains no active drug. It helps us compare the real medicine's effects.
Will I stop taking my current antidepressant?
No, this study involves adding the new medication or placebo to your current antidepressant, not replacing it.
How long will the study last?
The initial part of the study lasts about six weeks, with an option for a longer-term extension if you qualify and wish to continue.
Will I know if I'm getting the real medicine?
Neither you nor your study doctor will know whether you are receiving the active medication or the placebo until the study is finished.
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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