A Study to Test Different Doses of BI 1569912 in People With Depression
Public ClinicalTrials.gov record NCT06558344. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 6-week, Multi-centre, Randomised, Double-blind (Participant and Investigator), Placebo-controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 in Patients With Major Depressive Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06558344
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Interventions
- 5 mg BI 1569912 Drug
- Placebo matching BI 1569912 Drug
- 10 mg BI 1569912 Drug
- 20 mg of BI 1569912 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2024
- Primary completion
- May 1, 2025
- Completion
- May 11, 2025
- Last update posted
- May 21, 2026
2024 – 2025
United States locations
- U.S. sites
- 35
- U.S. states
- 14
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Innovations, Inc | Bellflower | California | 90706 | — |
| ASCLEPES Research Centers, P.C. dba Alliance Research | Long Beach | California | 90807 | — |
| Excell Research Inc. | Oceanside | California | 92056 | — |
| CiTrials-Riverside-63180 | Riverside | California | 92507 | — |
| Artemis Institute for Clinical Research, LLC | San Diego | California | 92103 | — |
| Lumos Clinical Research | San Jose | California | 95124 | — |
| California Neuroscience Research | Sherman Oaks | California | 91403 | — |
| Pacific Clinical Research Management Group LLC | Upland | California | 91786 | — |
| Research Centers of America-Hollywood-67537 | Hollywood | Florida | 33024 | — |
| Clinical Neuroscience Solutions, Inc-Jacksonville-62642 | Jacksonville | Florida | 32256 | — |
| CCM Clinical Research Group, LLC-Miami-68482 | Miami | Florida | 33133 | — |
| Optimus U Corporation-Miami-69452 | Miami | Florida | 33135 | — |
| Clinical Neuroscience Solutions, Inc-Orlando-62685 | Orlando | Florida | 32801 | — |
| Advanced Discovery Research LLC | Atlanta | Georgia | 30318 | — |
| iResearch Atlanta | Decatur | Georgia | 30030 | — |
| Psych Atlanta, PC | Marietta | Georgia | 30060 | — |
| Pharmasite Research, Incorporated | Baltimore | Maryland | 21208 | — |
| Copley Clinical | Boston | Massachusetts | 02116 | — |
| Boston Clinical Trials | Roslindale | Massachusetts | 02135 | — |
| Adams Clinical | Watertown | Massachusetts | 02472 | — |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | — |
| ActivMed | Portsmouth | New Hampshire | 03801 | — |
| Center For Emotional Fitness | Cherry Hill | New Jersey | 08002 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| Integrative Clinical Trials LLC | Brooklyn | New York | 11229 | — |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | — |
| Berman Clinical | New York | New York | 10029 | — |
| Davis Clinical | The Bronx | New York | 10461 | — |
| Sooner Clinical Research, Inc | Oklahoma City | Oklahoma | 73116 | — |
| Surburban Research Associates, Inc. | Media | Pennsylvania | 19063 | — |
| Clinical Neuroscience Solutions, Inc-Memphis-65988 | Memphis | Tennessee | 38119 | — |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75251 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Core Clinical Research | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06558344, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 21, 2026 · Synced Sep 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06558344 live on ClinicalTrials.gov.