A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Att… (NCT07001475) | Clinical Trial Compass
RecruitingPhase 1
A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder
Germany68 participantsStarted 2025-08-12
Plain-language summary
This study is open to adults with certain mental health conditions. The purpose of this study is to find out how a medicine called BI 3031185 is tolerated by people with certain mental health conditions.
Participants are put into 2 groups of equal size randomly, which means by chance. Group 1 takes a single dose of BI 3031185 and Group 2 takes placebo. After a 2-week break, Group 1 takes placebo and Group 2 takes a single dose of BI 3031185. Participants take BI 3031185 and placebo as tablets.
Participants are in the study for about 3 months. They visit the study site 6 times and have 3 phone or video call visits. For 2 of the visits, participants stay overnight at the study site for 2 nights. During all the visits, doctors check participants' health and take note of any unwanted effects.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. A single SSRI (selective serotonin re-uptake inhibitor) or SNRI (selective serotonin and norepinephrine re-uptake inhibitor) antidepressant that has been stable in dose and frequency for \>3 months prior to randomisation
. A single second-generation antipsychotic at a low dose that has been stable in dose and frequency for \>3 months prior to randomisation (low dose = 1 thorazine dose equivalent or less, which translates to ≤2 mg/day for risperidone, 5 mg/day for olanzapine, 75 mg/day for quetiapine, 60 mg/day for ziprasidone, and 7.5 mg/day for aripiprazole)
. A single sleep medication given as a nightly scheduled medication (not pro re nata) stable in agent and dose for \>3 months prior to screening. Allowed sleep medications include: non-benzodiazepine Z sleep medications, antihistamines, melatonin, trazodone, and doxepin
. Participants taking psychostimulant medication prescribed as per label for ADHD must stop medication 72 h prior to Visits 2 and 3 (Day -1) and may resume 24 h after receiving the medication dose on the test day (i.e. 5 days total off of prescribed psychostimulant for Visit 2 and 5 days off of prescribed psychostimulant for Visit 3)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily testing how safe and tolerable BI 3031185 is — not yet whether it works — what does that mean for me personally if I'm hoping for a direct treatment benefit?
2The study is measuring how many participants report side effects linked to this drug — what kinds of side effects are researchers watching for most closely in people with BPD or ADHD specifically?
3Given that this is an early-phase safety study, would enrolling here delay or interfere with any standard treatments I could be receiving right now for my BPD or ADHD?
4Are there different parts of this trial for BPD versus ADHD participants, and based on my specific diagnosis, which group would I be in and how might that affect what I experience in the study?
5What happens at the End of Study visit, and if I experience a side effect that's linked to the drug during the trial, what support or follow-up care would be available to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with borderline personality disorder (BPD) reporting adverse events (AEs) deemed by the investigator to be related to the investigational medicinal product (IMP) from IMP administration to End of Study (EoS)
Timeframe: Up to 28 days
2
Number of participants with attention deficit/hyperactivity disorder (ADHD) reporting AEs deemed by the investigator to be related to the IMP from IMP administration to EoS