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NCT06280235 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 243
- Enrollment target
NCT06280235: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT06280235 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 243 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06280235, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 243 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-reported interview guide which evaluates core symptoms of depression. It consists of 10 items and each item is rated on a scale from 0 (no abnormality) to 6 (severe). The possible total score could range from 0 to 60 (from normal with absence of symptoms to severe depression). The Least Squares Mean (95 % confidence interval) were estimated by restricted maximum likelihood-based mixed model for repeated measures (REML-based MMRM)
Interventions
- DRUG Placebo
- DRUG BI 1569912
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2024-03-27 |
| Est. Completion | 2025-03-28 |
| Phase | Phase 2 |
What the finished NCT06280235 record still lists
NCT06280235 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06280235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06280235 about?
NCT06280235 is a clinical study titled "A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine". 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 stand...
What is the current status of trial NCT06280235?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 243 participants. The study started on 2024-03-27. Estimated completion is 2025-03-28.
What interventions are being tested in trial NCT06280235?
The interventions under investigation include: Placebo (DRUG), BI 1569912 (DRUG).
Who is sponsoring clinical trial NCT06280235?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06280235's enrollment target sits among peer trials
243 236th of 2000 higher than 1,764 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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