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NCT04521478 · ClinicalTrials.gov registry record · Phase 2
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 389
- Enrollment target
NCT04521478: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04521478 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 389 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (192% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04521478, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 389 participants
- Enrollment target
Study Summary
This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study. Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only. Participants take BI 1358894, quetiapine, or placebo as tablets. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets twice a day. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.
Primary Outcome
Change from baseline in MADRS total score at Week 6 is reported. The MADRS evaluates core symptoms of depression and consists of 10 items. Nine of them 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). The possible total score could range from 0 (normal with absence of symptoms) to 60 (severe depression). Least squares mean and adjusted standard error we
Interventions
- DRUG Placebo
- DRUG Quetiapine
- DRUG BI 1358894
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2024-02-02 |
| Phase | Phase 2 |
What the finished NCT04521478 record still lists
NCT04521478 is an interventional study that assigns participants to a tested intervention. The registered 389 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 (192% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04521478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04521478 about?
NCT04521478 is a clinical study titled "A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression". This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI...
What is the current status of trial NCT04521478?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 389 participants. The study started on 2020-11-20. Estimated completion is 2024-02-02.
What interventions are being tested in trial NCT04521478?
The interventions under investigation include: Placebo (DRUG), Quetiapine (DRUG), BI 1358894 (DRUG).
Who is sponsoring clinical trial NCT04521478?
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 NCT04521478's enrollment target sits among peer trials
389 108th of 2000 higher than 1,892 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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