A phase II, double-blinded, placebo-controlled, clinical trial to determine the efficacy and safety of AP707 in the treatment of Borderline Personality Disorder.
This study is a clinical trial looking into a new medicine, AP707, for treating Borderline Personality Disorder (BPD). It's a 'phase 2' study, meaning researchers are checking if AP707 is helpful and safe. Some participants will receive AP707, while others will get a placebo (a pill with no active medicine), and neither the participants nor their doctors will know who is getting which. This helps ensure fair results. The main goal is to see if AP707 can reduce BPD symptoms more effectively than the placebo. They'll also be looking at how people generally feel and how well they manage their anger, as well as any side effects.
At a glance
What is this study about?
This study, called a clinical trial, is exploring a new medication called AP707. It's specifically designed for people who have been diagnosed with Borderline Personality Disorder (BPD). BPD is a mental health condition that can affect how a person thinks and feels about themselves and others, leading to difficulties in daily life.
The main purpose of this study is to find out two things: first, if AP707 can actually help improve the symptoms of BPD, and second, if it's safe for people to take. To do this, the study uses a common and fair method where some participants will receive AP707, and others will get a 'placebo' – which looks identical to AP707 but contains no active medicine. Neither you nor your study doctor will know which treatment you are receiving, which helps ensure the results are unbiased. This setup helps researchers confidently determine if any improvements are genuinely due to AP707.
This is a 'Phase 2' study, meaning it's an important early stage in testing a new medicine. If AP707 shows promising results in both helping with symptoms and being safe in this phase, it might move on to larger studies. The researchers will be carefully measuring changes in BPD symptoms and how participants generally feel throughout the study to understand the medicine's effects.
Key takeaways
- This study is testing a new medication, AP707, for Borderline Personality Disorder (BPD).
- It's a Phase II study, focusing on how well AP707 works and if it's safe.
- Participants will receive either AP707 or a placebo (dummy pill).
- Neither you nor your doctor will know which treatment you are getting.
- The study will involve regular visits and assessments to monitor your health and symptoms.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, you need to be an adult, 18 years of age or older. The study is open to both men and women.
Beyond these basic requirements, there will be other specific health conditions and medicine you might be taking that the study doctors will need to check. This is to make sure the study medication is safe for you and that the results of the study are clear. For example, if you have certain other medical conditions or are taking specific medications, you might not be able to join.
It's important to remember that meeting the basic age and gender criteria doesn't automatically mean you can join. A healthcare professional working on the study will review your full medical history and current health to determine if you're a good fit.
- Are you 18 years old or older?
- Do you have a diagnosis of Borderline Personality Disorder?
- Are you able to attend all scheduled study visits?
- Are you willing to potentially receive either the study drug or a placebo?
- Are you generally in good health apart from your BPD, or do you manage any other conditions well?
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'll be given either the new medicine, AP707, or a dummy pill (placebo) to take. You won't know which one you're getting, and neither will your local study doctor – this is common practice in studies to get the most accurate results.
Throughout the study, you'll have several visits to the study clinic. These visits will involve various assessments to see how you're feeling and how your symptoms are changing. You might be asked to complete questionnaires or have discussions with the study team. They will also keep an eye on your general health and check for any side effects.
The study will last for a certain period, and you'll have regular follow-up appointments. The exact number of visits and the total duration will be explained to you by the study team. It's important to attend all scheduled visits so the researchers can gather all the necessary information.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is Borderline Personality Disorder?
Borderline Personality Disorder (BPD) is a mental health condition that can affect how you think and feel about yourself and others, leading to intense emotions, difficulties with relationships, and impulsive behaviour.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the real study medicine but contains no active ingredients. It's used to fairly compare the new medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, this study is 'double-blinded,' meaning neither you nor your study doctor will know whether you are receiving AP707 or the placebo. This helps ensure fair and unbiased results.
What happens if I experience side effects?
The study team will monitor you closely for any side effects. If you experience any, you should tell the study team immediately so they can provide guidance and care.
Do I have to pay to join the study?
No, clinical trials usually cover the costs of the study medication and any study-related tests and appointments. You will not have to pay to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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