This study is open to adults between 18 and 65 years of age with a type of depression called major depressive disorder. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants are put into 4 groups randomly, which means by chance. Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks. Participants are in the study for about 2.5 months. During this time, they visit the study site at least 7 times. At the visits, doctors and their staff ask participants about their depression symptoms. At the end of the study, the results are compared between the groups to see whether the treatment works. The doctors also regularly check the general health of participants and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
225
Two 2.5 mg tablets of BI 1569912
Placebo matching BI 1569912
One 10 mg tablet of BI 1569912
Two 10 mg tablets of BI 1569912
Clinical Innovations, Inc
Bellflower, California, United States
ASCLEPES Research Centers, P.C. dba Alliance Research
Long Beach, California, United States
Excell Research Inc.
Oceanside, California, United States
CiTrials-Riverside-63180
Riverside, California, United States
Artemis Institute for Clinical Research, LLC
San Diego, California, United States
Change From Baseline in MADRS Total Score at Week 6
The change from baseline at Week 6 in the total Montgomery-Åsberg Depression Rating Scale (MADRS) score is reported, calculated as \[Week 6 MADRS score\] - \[Baseline MADRS score\]. The MADRS score assessed the severity of symptoms in people with depression, consisting of 10 items. Each item was rated from 0 (no symptom) to 6 (severe symptom), with a total score ranging from 0 to 60 (0 = normal/absence of symptoms, 60 = severe depression). The least squares mean and 95% confidence intervals were estimated by a mixed model for repeated measures (MMRM) including the fixed categorical effects of treatment at each time point and the number of antidepressant treatments taken for the current episode (0/1), and the baseline MADRS total score at each time point as fixed continuous effects. The time point is treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements.
Time frame: MMRM included measurements at baseline, Day 8, Week 2, Week 4, and Week 6. Change from baseline values at Week 6 is reported.
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