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
224
BI 1569912
Placebo matching 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 Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician reported interview guide designed to assess the severity of symptoms in depressive illness and to be sensitive to treatment effects. The MADRS consists of 10 items: 1. reported sadness 2. apparent sadness 3. inner tension 4. reduced sleep 5. reduced appetite 6. concentration difficulties 7. lassitude 8. inability to feel 9. pessimistic thought 10. suicidal thoughts Symptoms are rated on a 7-point Likert scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The possible total score could range from 0 to 60 (from normal with absence of symptoms to severe depression).
Time frame: at baseline and at Week 6
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Lumos Clinical Research
San Jose, California, United States
California Neuroscience Research
Sherman Oaks, California, United States
Pacific Clinical Research Management Group LLC
Upland, California, United States
Research Centers of America-Hollywood-67537
Hollywood, Florida, United States
Clinical Neuroscience Solutions, Inc-Jacksonville-62642
Jacksonville, Florida, United States
...and 31 more locations