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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514296-17-00 | Registry Identifier | CTIS | |
| U1111-1309-3549 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: BI 3031185 then placebo | Experimental |
| |
| Sequence 2: Placebo then BI 3031185 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3031185 | Drug | BI 3031185 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with BPD reporting any AEs from IMP administration to EoS | Up to 28 days | |
| Number of participants with ADHD reporting any AEs from IMP administration to EoS | Up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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)
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Recruiting | Berlin | 10117 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| Placebo | Drug | Placebo matching BI 3031185 |
|
| Universitätsklinikum Bonn AöR | Recruiting | Bonn | 53127 | Germany |
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| Universitätsklinikum Frankfurt | Recruiting | Frankfurt am Main | 60590 | Germany |
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| Martin-Luther-Universität Halle-Wittenberg | Recruiting | Halle | 06112 | Germany |
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| Rheinhessen-Fachklinik Mainz | Recruiting | Mainz | 55122 | Germany |
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| Zentralinstitut für seelische Gesundheit | Recruiting | Mannheim | 68159 | Germany |
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| Universitätsklinikum Tübingen | Recruiting | Tübingen | 72076 | Germany |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
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