Actively Recruiting
A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder
Led by Boehringer Ingelheim · Updated on 2026-04-15
96
Participants Needed
12
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, female, and non-binary participants, 18 to 45 years of age, both inclusively, at the time of consent
- Meet current DSM-5 criteria as primary diagnosis for borderline personality disorder (BPD) OR attention-deficit/hyperactivity disorder (ADHD) as assessed by the Mini International Neuropsychiatric Interview (MINI) at screening
- Willingness to abstain from alcohol for 24 hours and all other drugs of abuse including cannabis for 72 hours prior to Visits 2 and 3
- Willingness to abstain from alcohol and cannabis for 72 hours after investigational medicinal product administration, and from all other recreational drugs for the duration of the trial
- Willingness to abstain from prescribed psychostimulants for 72 hours prior to Visits 2 and 3 and 24 hours following investigational medicinal product administration
You will not qualify if you...
- Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, autism spectrum disorder, or antisocial personality disorder
- Any other psychiatric disorder not currently stable in symptoms and treatment
- 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 6 months prior to randomisation (excluding tobacco and caffeine)
- Positive drug screen except for cannabis users without moderate or severe use disorder as determined by the investigator
- Use of psychotropic medications other than a single stable SSRI or SNRI, a single low-dose second-generation antipsychotic, or a stable sleep medication
- Documented active or suspected malignancy or history of malignancy within 5 years prior to screening (except treated basal cell carcinoma or in situ carcinoma of uterine cervix)
- Positive result for any active hepatitis
- Previous randomisation in this trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Charité Research Organisation GmbH
Berlin, Germany, 10117
Actively Recruiting
2
Universitätsklinikum Bonn AöR
Bonn, Germany, 53127
Actively Recruiting
3
Technische Universität Dresden
Dresden, Germany, 01307
Not Yet Recruiting
4
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany, 60590
Actively Recruiting
5
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany, 06112
Actively Recruiting
6
Universitätsklinikum Hamburg, Eppendorf
Hamburg, Germany, 20251
Not Yet Recruiting
7
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Not Yet Recruiting
8
Zentrum Fuer Integrative Psychiatrie ZIP gGmbH Praevention-Therapie-Rehabilitation
Kiel, Germany, 24105
Not Yet Recruiting
9
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Not Yet Recruiting
10
Rheinhessen-Fachklinik Mainz
Mainz, Germany, 55122
Actively Recruiting
11
Zentralinstitut für seelische Gesundheit
Mannheim, Germany, 68159
Actively Recruiting
12
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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