A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
Public ClinicalTrials.gov record NCT04521478. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, 6-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial With a Quetiapine Arm to Evaluate the Efficacy, Tolerability and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04521478
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 389 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 19, 2020
- Primary completion
- Jan 9, 2024
- Completion
- Feb 1, 2024
- Last update posted
- Mar 5, 2025
2020 – 2024
United States locations
- U.S. sites
- 29
- U.S. states
- 15
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Collaborative Neuroscience Network, LLC (CNS) | Garden Grove | California | 92845 | — |
| Alliance Research | Long Beach | California | 90807 | — |
| Asclepes Research Centers | Sherman Oaks | California | 91403 | — |
| California Neuroscience Research | Sherman Oaks | California | 91403 | — |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | — |
| Viking Clinical Research, Ltd. | Temecula | California | 92591 | — |
| Collaborative Neuroscience Research, LLC | Torrance | California | 90504 | — |
| Mountain Mind. LLC | Denver | Colorado | 80202 | — |
| CT Clinical Research | Cromwell | Connecticut | 06416 | — |
| Institute of Living | Hartford | Connecticut | 06106 | — |
| Gulf Coast Clinical Research Center | Fort Myers | Florida | 33912 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32256 | — |
| Optimus U Corporation | Miami | Florida | 33135 | — |
| Advanced Discovery Research LLC | Atlanta | Georgia | 30318 | — |
| Atlanta Center | Atlanta | Georgia | 30331 | — |
| Chicago Research Center, Incorporated | Chicago | Illinois | 60634 | — |
| University of Kansas School of Medicine-Wichita | Wichita | Kansas | 67214 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | — |
| Center For Emotional Fitness | Cherry Hill | New Jersey | 08002 | — |
| Hassman Research Institute | Marlton | New Jersey | 08053 | — |
| Synexus Clinical Research US, Inc. | New York | New York | 10017 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | — |
| Global Medical Institutes, LLC, Scranton Medical Institute | Moosic | Pennsylvania | 18507 | — |
| Core Clinical Research | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 91 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04521478, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 5, 2025 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04521478 live on ClinicalTrials.gov.