Borderline Personality DisorderPhase 1NCT07001475
A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder
A Phase 1 study testing BI 3031185 in people with Borderline Personality Disorder and Attention Deficit Hyperactivity Disorder, run by Boehringer Ingelheim at 7 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Borderline Personality Disorder, Attention Deficit Hyperactivity Disorder
- What is being tested?
- BI 3031185
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 7 sitesGermany
- Study dates
- 12 Aug 2025to 6 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 international neuropsychiatric interview (MINI) at screening for borderline personality disorder (BPD) OR attention-deficit/hyperactivity disorder (ADHD). With full implementation of version 5.0 of this clinical trial protocol (CTP), only participants with a primary diagnosis of ADHD as assessed by the MINI will be included in the trial.
- 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
- Willingness to abstain from prescribed psychostimulants for 72 h prior to Visits 2 and 3 (Day -1) and 24 h following IMP administration Further inclusion criteria apply.
Who cannot join
- Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, autism spectrum disorder, or antisocial personality disorder as confirmed by the MINI
- 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)
- 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
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- 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)
- 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
- Previous randomisation in this trial Further exclusion criteria apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Charité Research Organisation GmbH
Berlin, 10117
Universitätsklinikum Bonn AöR
Bonn, 53127
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590
Martin-Luther-Universität Halle-Wittenberg
Halle, 06112
Rheinhessen-Fachklinik Mainz
Mainz, 55122
Zentralinstitut für seelische Gesundheit
Mannheim, 68159
Universitätsklinikum Tübingen
Tübingen, 72076
About this study
Official title: A Phase Ib, Multicentre, Randomised, Double Blind, Placebo Controlled, 2 Sequence Crossover Trial to Evaluate the Effects of BI 3031185 on Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics in Patients With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder
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.
- Being tested
- BI 3031185, Placebo
- Medical subject headings
- Borderline Personality Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3031185Drug
BI 3031185
PlaceboDrug
Placebo matching BI 3031185
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: BI 3031185 then placebo | Experimental | Not described Receives: Drug: BI 3031185; Drug: Placebo |
| Sequence 2: Placebo then BI 3031185 | Experimental | Not described Receives: Drug: BI 3031185; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 28 days
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
Measured: Up to 28 days
Secondary outcomes (2)
Number of participants with BPD reporting any AEs from IMP administration to EoS
Measured: Up to 28 days
Number of participants with ADHD reporting any AEs from IMP administration to EoS
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start12 Aug 2025
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001475
- Sponsor's protocol ID
- 1516-0003
- Other IDs
- 2024-514296-17-00, U1111-1309-3549
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multicentre, Randomised, Double Blind, Placebo Controlled, 2 Sequence Crossover Trial to Evaluate the Effects of BI 3031185 on Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics in Patients With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07001475
- Acronym / sponsor ID
- 1516-0003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: BI 3031185 then placebo | Experimental | Drug: BI 3031185, Drug: Placebo |
| Sequence 2: Placebo then BI 3031185 | Experimental | Drug: BI 3031185, Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 international neuropsychiatric interview (MINI) at screening for borderline personality disorder (BPD) OR attention-deficit/hyperactivity disorder (ADHD). With full implementation of version 5.0 of this clinical trial protocol (CTP), only participants with a primary diagnosis of ADHD as assessed by the MINI will be included in the trial.
- 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
- Willingness to abstain from prescribed psychostimulants for 72 h prior to Visits 2 and 3 (Day -1) and 24 h following IMP administration Further inclusion criteria apply.
Key exclusion criteria (12 listed)
- Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, autism spectrum disorder, or antisocial personality disorder as confirmed by the MINI
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 3031185BI 3031185 | Drug | Sequence 1: BI 3031185 then placebo, Sequence 2: Placebo then BI 3031185 |
| PlaceboPlacebo matching BI 3031185 | Drug | Sequence 1: BI 3031185 then placebo, Sequence 2: Placebo then BI 3031185 |
Primary outcome
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)
Time frame: Up to 28 days
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
Time frame: Up to 28 days
2 secondary outcomes
Number of participants with BPD reporting any AEs from IMP administration to EoS
Time frame: Up to 28 days
Number of participants with ADHD reporting any AEs from IMP administration to EoS
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 3031185 in people with Borderline Personality Disorder and Attention Deficit Hyperactivity Disorder, run by Boehringer Ingelheim at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.