A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder
NCT ID: NCT07001475
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
96 participants
INTERVENTIONAL
2025-08-12
2026-05-27
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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BPD Sequence 1: BI 3031185 then placebo
BI 3031185
BI 3031185
Placebo
Placebo matching BI 3031185
BPD Sequence 2: Placebo then BI 3031185
BI 3031185
BI 3031185
Placebo
Placebo matching BI 3031185
ADHD Sequence 1: BI 3031185 then placebo
BI 3031185
BI 3031185
Placebo
Placebo matching BI 3031185
ADHD Sequence 2: Placebo then BI 3031185
BI 3031185
BI 3031185
Placebo
Placebo matching BI 3031185
Interventions
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BI 3031185
BI 3031185
Placebo
Placebo matching BI 3031185
Eligibility Criteria
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Inclusion Criteria
* Meet current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria as primary diagnosis as assessed by the Mini International Neuropsychiatric 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 including cannabis for 72 h prior to Visits 2 and 3 (Day -1). Willingness to abstain from alcohol and cannabis for 72 h after investigational medicinal product (IMP) administration, as well as from all other recreational drugs for the duration of the trial
Exclusion Criteria
* Any other psychiatric disorder that is not currently stable in symptoms and treatment
* Any substance use disorder within 3 months prior to randomisation (excluding mild alcohol, cannabis, tobacco, and caffeine use disorders); or moderate to severe substance use disorder within the 6 months prior to randomisation (excluding tobacco and caffeine)
* Positive drug screen. Participants with positive cannabis drug tests can be included if they do not meet criteria for moderate or severe cannabis use disorder and the investigator determines that use will not be an impediment to trial participation or accurate data collection
* Concomitant use of psychotropic medication except for the ones below. All other psychotropic 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 (selective serotonin and norepinephrine re-uptake inhibitor) antidepressant that has been stable in dose and frequency for \>3 months prior to randomisation
2. 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)
3. 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
4. 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)
* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix
* A positive result for any active hepatitis
18 Years
45 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Charité Research Organisation GmbH
Berlin, , Germany
Universitätsklinikum Bonn AöR
Bonn, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, , Germany
Universitätsklinikum Jena
Jena, , Germany
Rheinhessen-Fachklinik Mainz
Mainz, , Germany
Zentralinstitut für seelische Gesundheit
Mannheim, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Related Links
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Related Info
Other Identifiers
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2024-514296-17-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1309-3549
Identifier Type: REGISTRY
Identifier Source: secondary_id
1516-0003
Identifier Type: -
Identifier Source: org_study_id