A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine
Public ClinicalTrials.gov record NCT06280235. 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 Phase II, 6-week, Multicenter, Randomized, Double Blind (Patient and Investigator) or Masked, Placebo Controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 as Adjunctive Therapy in MD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults between 18 and 65 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants continue their standard therapy throughout the study. Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 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 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms. The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants.
Study identification
- NCT ID
- NCT06280235
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 243 participants
Conditions and interventions
Conditions
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
- Mar 26, 2024
- Primary completion
- Feb 25, 2025
- Completion
- Mar 27, 2025
- Last update posted
- Mar 26, 2026
2024 – 2025
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Biomedical Research, LLC | Tucson | Arizona | 85712 | — |
| Excell Research Inc. | Oceanside | California | 92056 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Asclepes Research Centers-Panorama City-62905 | Panorama City | California | 91402 | — |
| CT Clinical Research | Cromwell | Connecticut | 06416 | — |
| Galiz Research | Hialeah | Florida | 33016 | — |
| Premier Clinical Research Institute | Miami | Florida | 33122 | — |
| CCM Clinical Research Group, LLC-Miami-68482 | Miami | Florida | 33133 | — |
| iResearch Atlanta | Decatur | Georgia | 30030 | — |
| Chicago Research Center, Incorporated | Chicago | Illinois | 60634 | — |
| ActivMed Practices & Research | Methuen | Massachusetts | 01844 | — |
| Boston Clinical Trials | Roslindale | Massachusetts | 02135 | — |
| Adams Clinical | Watertown | Massachusetts | 02472 | — |
| Hassman Research Institute-Marlton-66897 | Marlton | New Jersey | 08053 | — |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | — |
| Midwest Clinical Research | Dayton | Ohio | 45417 | — |
| Neuro-Behavioral Clinical Research | North Canton | Ohio | 44720 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Houston Clinical Trials, LLC | Bellaire | Texas | 77401 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
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 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06280235, 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 Mar 26, 2026 · Synced Sep 26, 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 NCT06280235 live on ClinicalTrials.gov.