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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
BI 3031185
Placebo matching BI 3031185
Charité Research Organisation GmbH
Berlin, Germany
Universitätsklinikum Bonn AöR
Bonn, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany
Rheinhessen-Fachklinik Mainz
Mainz, Germany
Zentralinstitut für seelische Gesundheit
Mannheim, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
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
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
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