A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
Status:
Recruiting
Trial end date:
2023-02-22
Target enrollment:
Participant gender:
Summary
This study is open to adults with depression (major depressive disorder) for whom standard
treatment with antidepressants alone does not work sufficiently. The purpose of the trial is
to find out whether a medicine called BI 1358894 helps to improve symptoms of depression.
Four different doses of BI 1358894 are tested in the study. Participants continue their
standard antidepressant therapy throughout the study.
Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take
different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine,
a medicine already used to treat depression, and placebo. Participants in the sixth group
take placebo only.
Participants take BI 1358894, quetiapine, or placebo as tablets twice a day. Placebo tablets
look like BI 1358894 or quetiapine tablets but do not contain any medicine.
Participants are in the study for about 3 months. During this time, they visit the study site
about 8 times and get about 2 phone calls. At the visits, doctors ask participants about
their symptoms.
The results between the BI 1358894 groups, the quetiapine group, and the placebo group are
then compared. The doctors also regularly check the general health of the participants.