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A Study to Test Different Doses of BI 1569912 in People With Depression
NCT06558344 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG BI 1569912
- DRUG Placebo matching BI 1569912
Study Locations (20)
California
- Clinical Innovations, Inc — Bellflower
- ASCLEPES Research Centers, P.C. dba Alliance Research — Long Beach
- Excell Research Inc. — Oceanside
- CiTrials-Riverside-63180 — Riverside
- Artemis Institute for Clinical Research, LLC — San Diego
- Lumos Clinical Research — San Jose
- California Neuroscience Research — Sherman Oaks
- Pacific Clinical Research Management Group LLC — Upland
Florida
- Research Centers of America-Hollywood-67537 — Hollywood
- Clinical Neuroscience Solutions, Inc-Jacksonville-62642 — Jacksonville
- CCM Clinical Research Group, LLC-Miami-68482 — Miami
- Optimus U Corporation-Miami-69452 — Miami
- Clinical Neuroscience Solutions, Inc-Orlando-62685 — Orlando
Georgia
- Advanced Discovery Research LLC — Atlanta
- iResearch Atlanta — Decatur
- Psych Atlanta, PC — Marietta
Massachusetts
- Copley Clinical — Boston
- Boston Clinical Trials — Roslindale
- Adams Clinical — Watertown
Maryland
- Pharmasite Research, Incorporated — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2025-05-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06558344
The ClinicalTrials.gov registry entry for NCT06558344 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions — of which BI 1569912 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06558344 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06558344 about?
NCT06558344 is a clinical study titled "A Study to Test Different Doses of BI 1569912 in People With Depression". 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. Thre...
What is the current status of trial NCT06558344?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2024-10-01. Estimated completion is 2025-05-12.
What conditions does trial NCT06558344 study?
This clinical trial studies the following conditions: Depressive Disorder, Major. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06558344?
The interventions under investigation include: BI 1569912 (DRUG), Placebo matching BI 1569912 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06558344?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06558344 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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