A Study to Test Different Doses of BI 1569912 in People With Depression
- Conditions
- Depressive Disorder, Major
- Interventions
- Drug: Placebo matching BI 1569912
- Registration Number
- NCT06558344
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo matching BI 1569912 Placebo matching BI 1569912 - BI 1569912 (medium dose) BI 1569912 - BI 1569912 (low dose) BI 1569912 - BI 1569912 (high dose) BI 1569912 -
- Primary Outcome Measures
Name Time Method Change from baseline in MADRS total score at Week 6 at baseline and 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Surburban Research Associates, Inc.
🇺🇸Media, Pennsylvania, United States
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
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
CCM Clinical Research Group, LLC-Miami-68482
🇺🇸Miami, Florida, United States
Optimus U Corporation-Miami-69452
🇺🇸Miami, Florida, United States
Clinical Neuroscience Solutions, Inc-Orlando-62685
🇺🇸Orlando, Florida, United States
Advanced Discovery Research LLC
🇺🇸Atlanta, Georgia, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Psych Atlanta, PC
🇺🇸Marietta, Georgia, United States
Pharmasite Research, Incorporated
🇺🇸Baltimore, Maryland, United States
Copley Clinical
🇺🇸Boston, Massachusetts, United States
Boston Clinical Trials
🇺🇸Roslindale, Massachusetts, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
Psychiatric Care and Research Center
🇺🇸O'Fallon, Missouri, United States
ActivMed
🇺🇸Portsmouth, New Hampshire, United States
Center For Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Davis Clinical
🇺🇸Bronx, New York, United States
Integrative Clinical Trials LLC
🇺🇸Brooklyn, New York, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Berman Clinical
🇺🇸New York, New York, United States
Sooner Clinical Research, Inc
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Neuroscience Solutions, Inc-Memphis-65988
🇺🇸Memphis, Tennessee, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Core Clinical Research
🇺🇸Everett, Washington, United States
Uematsu Mental Clinic
🇯🇵Fukuoka, Chikugo, Japan
Kaku Mental Clinic
🇯🇵Fukuoka, Fukuoka, Japan
Hirota Clinic
🇯🇵Fukuoka, Kurume, Japan
Yutaka Clinic
🇯🇵Kanagawa,Sagamihara, Japan
Maynds Tower Mental Clinic
🇯🇵Tokyo, Shibuya-ku, Japan
Ichigaya Himorogi Clinic
🇯🇵Tokyo, Shinjuku-ku, Japan