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NCT06558344 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Different Doses of BI 1569912 in People With Depression
A Phase 2 study of Depressive Disorder, Major, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 224
- Enrollment target
- 20
- Study locations
NCT06558344: Completed Phase 2 study of Depressive Disorder, Major, sponsored by Boehringer Ingelheim.
NCT06558344 is a Phase 2 study of Depressive Disorder, Major that has completed, run by Boehringer Ingelheim. The registered enrollment target is 224 participants, roughly in line with the 238-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06558344, a Phase 2 study of Depressive Disorder, Major, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 224 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The change from baseline at Week 6 in the total Montgomery-Åsberg Depression Rating Scale (MADRS) score is reported, calculated as \[Week 6 MADRS score\] - \[Baseline MADRS score\]. The MADRS score assessed the severity of symptoms in people with depression, consisting of 10 items. Each item was rated from 0 (no symptom) to 6 (severe symptom), with a total score ranging from 0 to 60 (0 = normal/absence of symptoms, 60 = severe depression). The least squares mean and 95% confidence intervals were
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 |
What the finished NCT06558344 record still lists
NCT06558344 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 238-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target.
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.
NCT06558344 names 20 study sites across 5 states, led by California, Florida, Georgia.
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.
What interventions are being tested in trial NCT06558344?
The interventions under investigation include: BI 1569912 (DRUG), Placebo matching BI 1569912 (DRUG).
Who is sponsoring clinical trial NCT06558344?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06558344's enrollment target sits among peer trials
224 22nd of 52 higher than 31 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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