An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Researchers are looking for adults and older people with major depressive disorder to take part in a long-term study. This study is testing a new medication called JNJ-67953964. The goal is to find out if this new medicine is safe and helps to improve symptoms of depression when taken alongside current treatments. Doctors will keep a close eye on participants' general health, including their vital signs, weight, and any potential side effects. They will also assess changes in mood, sexual function, and any withdrawal symptoms if the medication is stopped. This is an important step in understanding if JNJ-67953964 could be a helpful new treatment option for depression.
At a glance
What is this study about?
This study is focused on a new medication, JNJ-67953964, for people who have been diagnosed with major depressive disorder. Major depressive disorder, or MDD, is a common and serious illness that can affect how you feel, think, and behave, often leading to a range of emotional and physical problems. The aim of this study is to see if adding JNJ-67953964 to existing treatments can safely and effectively help improve symptoms over a long period.
This type of study is called a 'Phase III' clinical trial. This means it's one of the final steps before a new medicine might be made available to everyone. It involves a larger group of people to confirm the results found in earlier studies. Researchers want to make sure the medicine is well-tolerated and provides real benefits for people living with depression.
During the study, doctors and nurses will regularly check on participants' health. They will look for any side effects, changes in physical health like blood pressure or weight, and how a person's mood or other symptoms of depression are changing. They will also check for any potential withdrawal symptoms if treatment is stopped and look at effects on things like sexual health. This detailed monitoring helps ensure the safety of participants and gives a full picture of how the new medicine works.
Key takeaways
- This study is testing a new medication for depression.
- It aims to see if it's safe and effective when used alongside current treatments.
- Participation involves regular health checks and symptom assessments.
- It's a long-term study for adults with major depressive disorder.
- You would be closely monitored by a healthcare team.
Who may be eligible?
This study is looking for adults who have been diagnosed with major depressive disorder. There's no upper age limit, meaning both younger adults and older individuals can take part.
To be considered for the study, you would need to meet certain health criteria that the doctors running the study have set. These criteria are in place to make sure the study is safe for you and that the results are clear.
Both men and women are welcome to participate. If you're interested, the study team would have a detailed chat with you about your health history to see if it's a good fit.
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 depressive disorder?
- Are you currently receiving treatment for your depression?
- Are you able to attend regular clinic visits?
What does participation involve?
If you decide to take part in this study, you would receive the new study medication, JNJ-67953964, alongside your current treatment for depression. This isn't a short-term study; it's designed to observe effects over a long period to understand how the medicine works over time.
Your involvement would include regular visits to the clinic. During these visits, doctors and nurses would perform various assessments. This includes checking your vital signs (like blood pressure and heart rate), measuring your weight, taking blood and urine samples, and performing heart checks (ECGs). You would also regularly complete questionnaires about your mood, depression symptoms, and any side effects you might be experiencing, including effects on sexual function. If you stop the medication, they will also monitor for any withdrawal symptoms. The total duration of your participation would be explained in detail by the study team.
Potential risks and benefits
Locations (11)
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- —UnverifiedSpain
Common questions
What is 'Major Depressive Disorder'?
It's a serious and common mood disorder that can cause severe symptoms that affect how you feel, think, and handle daily activities, like sleeping, eating, or working.
What kind of medicine is JNJ-67953964?
It's a new medication being tested to see if it can help improve symptoms of depression when added to a person's current treatment.
What is a 'Phase III' study?
It's a large study, usually one of the last steps before a new medicine is considered for wider use, looking closely at safety and how well it works.
Will I have to stop my current depression medicine?
No, this study is testing the new medicine as an 'adjunctive therapy,' meaning it's added to your existing treatment.
What will doctors check during the study?
They will check your general health, blood pressure, weight, heart, blood results, and ask you specific questions about your mood, symptoms, and any side effects you might have.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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