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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 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 389 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04521478
The ClinicalTrials.gov registry entry for NCT04521478 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 389 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04521478 reports 0 study locations.
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.
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