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NCT04423757 · ClinicalTrials.gov registry record · Phase 2
A Home-based Study Using Mobile Technology to Test Whether BI 1358894 is Effective in People With Depression
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT04423757: Clinical Trial Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04423757 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04423757, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
This is a home-based study in adults with depression. People who have been diagnosed with Major Depressive Disorder can participate in the study. Participants can take part if they are being treated for their depression but still have symptoms. The purpose of this study is to find out whether a medicine called BI 1358894 helps people with depression. Participants are in the study for about 2 months and do not need to visit a study site during this time. All study visits are conducted at participant's home by a mobile study nurse, by videoconference, and by phone calls. Participants are put into 2 groups by chance. One group takes BI 1358894 tablets. The other group takes placebo tablets. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. The participants answer questions about the symptoms of their depression. We then compare the results between the BI 1358894 and placebo groups. The doctors and nurses also regularly check the general health of the participants.
Primary Outcome
The Montgomery-Åsberg Depression Rating Scale (MADRS) evaluates core symptoms of depression. Nine of the items are based upon participant reports, and one is on the rater's observation (apparent sadness) during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). Total score is calculated by the sum of the individual items, the possible total score could range from 0 to 60 (0= normal with absence of symptoms, 60=severe depression). The adjusted mean (SE) a
Interventions
- DRUG Placebo
- DRUG BI 1358894
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-06-22 |
| Est. Completion | 2022-05-08 |
| Phase | Phase 2 |
Why NCT04423757 stopped before completion
NCT04423757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04423757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04423757 about?
NCT04423757 is a clinical study titled "A Home-based Study Using Mobile Technology to Test Whether BI 1358894 is Effective in People With Depression". This is a home-based study in adults with depression. People who have been diagnosed with Major Depressive Disorder can participate in the study. Participants can take part if they are being treated for their depression but still have symptoms. The purpose of this study is to find out whether a medi...
What is the current status of trial NCT04423757?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2020-06-22. Estimated completion is 2022-05-08.
What interventions are being tested in trial NCT04423757?
The interventions under investigation include: Placebo (DRUG), BI 1358894 (DRUG).
Who is sponsoring clinical trial NCT04423757?
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 NCT04423757's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 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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