A Home-based Study Using Mobile Technology to Test Whether BI 1358894 is Effective in People With Depression
Status:
Recruiting
Trial end date:
2022-12-26
Target enrollment:
Participant gender:
Summary
This is a home-based study in adults with depression. People who have been diagnosed with
Major Depressive Disorder can participate in the study. Participants can take part if they
are being treated for their depression but still have symptoms. The purpose of this study is
to find out whether a medicine called BI 1358894 helps people with depression.
Participants are in the study for about 2 months and do not need to visit a study site during
this time. All study visits are conducted at participant's home by a mobile study nurse, by
videoconference, and by phone calls. Participants are put into 2 groups by chance. One group
takes BI 1358894 tablets. The other group takes placebo tablets. Placebo tablets look like BI
1358894 tablets but do not contain any medicine.
The participants answer questions about the symptoms of their depression. We then compare the
results between the BI 1358894 and placebo groups. The doctors and nurses also regularly
check the general health of the participants.