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

Last updated: May 22, 2026
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

1

Condition

Borderline Personality Disorder

Mood Disorders

Williams Syndrome

Treatment

Placebo

BI 3031185

Clinical Study ID

NCT07001475
1516-0003
2024-514296-17-00
U1111-1309-3549
  • Ages 18-45
  • All Genders

Study Summary

This study is open to adults with borderline personality disorder (BPD) and with attention deficit/ hyperactivity disorder (ADHD). The purpose of this study is to find out how a medicine called BI 3031185 is tolerated by people with BPD or ADHD.

Participants with BPD with ADHD are in separate cohorts. Participants from each cohort 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 1 to 2 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male, female, and non-binary participants, 18 to 45 years of age, both inclusively,at the time of consent

  • Meet current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria as primary diagnosis as assessed by the Mini InternationalNeuropsychiatric Interview (MINI) at screening for borderline personality disorder (BPD) OR attention-deficit/hyperactivity disorder (ADHD)

  • Willingness to abstain from alcohol for 24 h, and all other drugs of abuse includingcannabis for 72 h prior to Visits 2 and 3 (Day -1). Willingness to abstain fromalcohol and cannabis for 72 h after investigational medicinal product (IMP)administration, as well as from all other recreational drugs for the duration of thetrial

  • Willingness to abstain from prescribed psychostimulants for 72 h prior to Visits 2and 3 (Day -1) and 24 h following IMP administration Further inclusion criteriaapply

Exclusion

Exclusion Criteria:

  • Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniformdisorder, bipolar I disorder, delusional disorder, autism spectrum disorder, orantisocial personality disorder as confirmed by the MINI

  • Any other psychiatric disorder that is not currently stable in symptoms andtreatment

  • Any substance use disorder within 3 months prior to randomisation (excluding mildalcohol, cannabis, tobacco, and caffeine use disorders); or moderate to severesubstance use disorder within the 6 months prior to randomisation (excluding tobaccoand caffeine)

  • Positive drug screen. Participants with positive cannabis drug tests can be includedif they do not meet criteria for moderate or severe cannabis use disorder and theinvestigator determines that use will not be an impediment to trial participation oraccurate data collection

  • Concomitant use of psychotropic medication except for the ones below. All otherpsychotropic medications must be washed out at least 30 days or 5 Half-life time (t1/2) (whichever is longer) before the start of Visit 2 (Day -1)

  1. A single SSRI (selective serotonin re-uptake inhibitor) or SNRI (selectiveserotonin and norepinephrine re-uptake inhibitor) antidepressant that has beenstable in dose and frequency for >3 months prior to randomisation

  2. A single second-generation antipsychotic at a low dose that has been stable indose and frequency for >3 months prior to randomisation (low dose = 1 thorazinedose equivalent or less, which translates to ≤2 mg/day for risperidone, 5mg/day for olanzapine, 75 mg/day for quetiapine, 60 mg/day for ziprasidone, and 7.5 mg/day for aripiprazole)

  3. A single sleep medication given as a nightly scheduled medication (not pro renata) stable in agent and dose for >3 months prior to screening. Allowed sleepmedications include: non-benzodiazepine Z sleep medications, antihistamines,melatonin, trazodone, and doxepin

  4. Participants taking psychostimulant medication prescribed as per label for ADHDmust stop medication 72 h prior to Visits 2 and 3 (Day -1) and may resume 24 hafter receiving the medication dose on the test day (i.e. 5 days total off ofprescribed psychostimulant for Visit 2 and 5 days off of prescribedpsychostimulant for Visit 3)

  • Any documented active or suspected malignancy or history of malignancy within 5years prior to screening, except appropriately treated basal cell carcinoma of theskin or in situ carcinoma of uterine cervix

  • A positive result for any active hepatitis

  • Previous randomisation in this trial Further exclusion criteria apply

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
August 12, 2025
Estimated Completion Date:
November 27, 2026

Connect with a study center

  • Rheinhessen-Fachklinik Alzey

    Alzey, 55232
    Germany

    Site Not Available

  • Charité Research Organisation GmbH

    Berlin, 10117
    Germany

    Active - Recruiting

  • Charité Research Organisation GmbH

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • Universitätsklinikum Bonn AöR

    Bonn, 53127
    Germany

    Active - Recruiting

  • Universitätsklinikum Bonn AöR

    Bonn 2946447, 53127
    Germany

    Site Not Available

  • Technische Universität Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590
    Germany

    Active - Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt am Main 2925533, 60590
    Germany

    Site Not Available

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, 06112
    Germany

    Active - Recruiting

  • Martin-Luther-Universität Halle-Wittenberg

    Halle 2911522, 06112
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg, Eppendorf

    Hamburg, 20251
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hanover, 30625
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena, 07743
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena 2895044, 07743
    Germany

    Site Not Available

  • Zentrum Fuer Integrative Psychiatrie ZIP gGmbH Praevention-Therapie-Rehabilitation

    Kiel, 24105
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • Rheinhessen-Fachklinik Mainz

    Mainz, 55122
    Germany

    Active - Recruiting

  • Rheinhessen-Fachklinik Mainz

    Mainz 2874225, 55122
    Germany

    Site Not Available

  • Zentralinstitut für seelische Gesundheit

    Mannheim, 68159
    Germany

    Active - Recruiting

  • Zentralinstitut für seelische Gesundheit

    Mannheim 2873891, 68159
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen

    Tübingen 2820860, 72076
    Germany

    Site Not Available

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