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RecruitingPHASE1INTERVENTIONAL

A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder

This study aims to discover how a new medicine, BI 3031185, is tolerated by adults living with Borderline Personality Disorder (BPD) or Attention Deficit Hyperactivity Disorder (ADHD). Participants will be split into two groups, with one group receiving BI 3031185 and the other a placebo (a dummy pill). After a two-week break, the groups will swap over. This helps researchers compare the effects of the new medicine against no medicine. Doctors will carefully check participants' health during regular visits, including some overnight stays. The study involves about 1 to 2 months of participation, with a total of six in-person visits and three phone or video calls, to ensure any potential side effects are recorded.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Boehringer Ingelheim
Enrolment target
96
Start
12 Aug 2025
Estimated completion
27 Nov 2026

What is this study about?

This study is looking into a new medicine called BI 3031185. It’s designed specifically for adults who have either Borderline Personality Disorder (BPD) or Attention Deficit Hyperactivity Disorder (ADHD). The main goal is to see how well people tolerate this new medicine – meaning, how their bodies react to it and if it causes any unwanted effects.

Participants will be divided into two groups by chance, like flipping a coin. One group will receive the new medicine, BI 3031185, while the other group will receive a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps researchers understand if any changes are due to the medicine itself or other factors. After two weeks, the groups will switch, so everyone gets a chance to try both the new medicine and the placebo. Both the medicine and the placebo will be given as tablets.

By carefully comparing what happens when people take BI 3031185 versus the placebo, doctors can learn more about its safety and how the body handles it. They will keep a close eye on everyone's health throughout the study to make sure it's as safe as possible and to record any effects, good or bad.

Key takeaways

  • This study tests a new medicine (BI 3031185) for BPD and ADHD.
  • It aims to see how well people tolerate the new medicine.
  • Participants will receive both the medicine and a placebo at different times.
  • It involves regular clinic visits, including some overnight stays.
  • The study lasts about 1 to 2 months.
  • You must be 18-45 years old with a BPD or ADHD diagnosis.

Who may be eligible?

This study is looking for both men, women, and non-binary individuals who are between 18 and 45 years old. To take part, you must have a clear diagnosis of either Borderline Personality Disorder (BPD) or Attention Deficit Hyperactivity Disorder (ADHD).

There are also some important lifestyle requirements. You'll need to be willing to avoid alcohol for 24 hours before certain visits and for 72 hours after taking the study medicine. All other recreational drugs, including cannabis, need to be avoided for 72 hours before specific visits and 72 hours after the study medicine, and for the entire study duration. If you take prescribed stimulants for ADHD, you'll need to stop them for 72 hours before certain visits and 24 hours after taking the study medicine.

You cannot join this study if you've ever had certain mental health conditions like schizophrenia or bipolar disorder. You also can't participate if you have an unstable mental health condition or a recent history of moderate to severe substance use issues. If you test positive for drugs, you may still be able to join if it's not a severe issue and the study doctor agrees.

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.

  1. Are you between 18 and 45 years old?
  2. Do you have a diagnosis of Borderline Personality Disorder or Attention Deficit Hyperactivity Disorder?
  3. Are you able to avoid alcohol and recreational drugs for specific periods during the study?
  4. Are you able to temporarily stop prescribed stimulant medications if applicable?
  5. Have you ever been diagnosed with conditions like schizophrenia or bipolar disorder?
  6. Do you have any other unstable mental health conditions or recent severe substance use issues?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about 1 to 2 months. During this time, you will have six visits to the study clinic and three check-ups over the phone or by video call. For two of the hospital visits, you will need to stay overnight for two nights each time. This is so the doctors can closely monitor your health and how you respond to the medicine. You will take the study medicine (either BI 3031185 or the placebo) as tablets. Throughout all your visits, doctors will regularly check your health and make a note of any effects, especially unwanted ones, to ensure your safety.

Potential risks and benefits

Taking part in a study like this helps researchers learn more about new potential treatments, which could eventually benefit many people. However, there's no guarantee the medicine will help you personally. You might experience side effects from the study medicine, or even from the placebo. All potential risks will be explained to you before you agree to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (9)

  • Charité Research Organisation GmbH
    Verified postcode
    Berlin, Germany· Recruiting
  • Universitätsklinikum Bonn AöR
    Verified postcode
    Bonn, Germany· Recruiting
  • Technische Universität Dresden
    Verified postcode
    Dresden, Germany· Not yet recruiting
  • Universitätsklinikum Frankfurt
    Verified postcode
    Frankfurt am Main, Germany· Recruiting
  • Martin-Luther-Universität Halle-Wittenberg
    Verified postcode
    Halle, Germany· Recruiting
  • Universitätsklinikum Hamburg, Eppendorf
    Verified postcode
    Hamburg, Germany· Not yet recruiting
  • Rheinhessen-Fachklinik Mainz
    Verified postcode
    Mainz, Germany· Recruiting
  • Zentralinstitut für seelische Gesundheit
    Verified postcode
    Mannheim, Germany· Recruiting
  • Universitätsklinikum Tübingen
    Verified postcode
    Tübingen, Germany· Recruiting

Common questions

What is a placebo?

A placebo is a 'dummy' pill that looks like the real medicine but doesn’t contain any active ingredients. It helps researchers compare the effects of the new medicine to not having any active treatment.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know at the time. This is called 'blinding' and helps ensure the results are accurate. Both you and the study team won't know until after the study is complete, or in an emergency.

How long will I be in the study?

The study will last for about 1 to 2 months from your first visit to your last checks.

Do I have to stay overnight at the clinic?

Yes, for two of your visits, you will need to stay overnight at the study clinic for two nights each time.

Can I drink alcohol or use recreational drugs during the study?

You will need to avoid alcohol for specific periods around your visits and after taking the study medicine. All recreational drugs, including cannabis, must be avoided for certain periods and for the entire duration of the trial.

How to find out more

Boehringer Ingelheim

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Test How BI 3031185 is Tolerated by People With B…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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