Testing BI 1569912 for Major Depressive Disorder in Patients Using Antidepressants

What is this study about?

This clinical trial is focused on studying major depressive disorder, a condition characterized by persistent feelings of sadness and loss of interest. The trial will test different doses of a new medication called BI 1569912, which is being developed as an additional treatment for people already taking anti-depressive medicine. The purpose of the study is to evaluate how effective, tolerable, and safe this medication is when used alongside existing treatments for depression.

Participants in the study will be randomly assigned to receive either the medication BI 1569912 or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations. The trial will last for six weeks, during which time participants will continue their current anti-depressive treatment while also taking the study medication or placebo.

Throughout the study, participants will have regular check-ups to monitor their symptoms and overall health. The main focus will be on changes in depression symptoms, as measured by a standard scale used to assess the severity of depression. The study aims to find the most effective dose of BI 1569912 and to understand how it can best help people with major depressive disorder when used in combination with their current treatment.

1 randomization

Upon joining the study, participants are randomly assigned to receive either the study medication BI 1569912 or a placebo. This process is double-blind, meaning neither the participant nor the investigator knows which treatment is being administered.

2 medication administration

Participants take the assigned oral medication daily for a period of 6 weeks. The specific dosage of BI 1569912 is determined during the randomization process.

3 initial assessment

On Day 8, participants undergo an assessment to measure changes in their depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS). This scale helps evaluate the severity of depression.

4 ongoing assessments

Throughout the 6-week trial, participants continue to be monitored for changes in their depression symptoms. Additional assessments are conducted at Week 4 and Week 6 using the MADRS and the Symptoms of Major Depressive Disorder Scale (SMDDS).

5 final assessment

At the end of the 6-week period, a final assessment is conducted to evaluate the overall change in depression symptoms. The goal is to determine if there has been a significant reduction in symptoms or if remission has been achieved.

Who Can Join the Study?

Participants must be male or female and between 18 to 65 years old at the time they agree to join the study.
Participants need to provide a signed and dated written informed consent before joining the trial. This means they understand the study and agree to participate.
Women who can have children must use a highly effective birth control method that has a very low chance of failing, less than 1% per year, and use an additional barrier method. Details about these methods are given in the study information.
Participants must have a confirmed diagnosis of Major Depressive Disorder (MDD), either a single episode or recurring, with the current depressive episode lasting at least 8 weeks at the time of the screening visit.
Participants must have a score of more than 17 on the Hamilton Depression Rating Scale-17 (HDRS-17), which measures the severity of depression.
Participants should be on a single ongoing treatment for at least 6 weeks with a type of antidepressant called SSRI or SNRI at an adequate dose. They must continue this dose until the end of the study. They should have been on a stable dose for at least 4 weeks before joining the study. If they are taking additional low-dose antidepressants for reasons other than depression, they can still participate as long as the dose is less than the lowest dose used for MDD.
In the current depressive episode, participants must have shown insufficient response to up to 4 different antidepressant treatments at adequate doses and durations, meaning they have not improved by more than 50%.
There are additional criteria that participants must meet to join the study.

Who Cannot Join the Study?

Patients who have a different condition than major depressive disorder cannot participate. This means the study is only for those diagnosed with this specific mental health condition.
Individuals who are not within the specified age range cannot join. The study is designed for certain age groups only.
Participants who are not part of the specified clinical trial groups are excluded. This means only certain groups of people are eligible.
Both males and females can participate, so gender is not a reason for exclusion.
People who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Medical Center Hera EOOD	Sofia	Bulgaria
INEP medical s.r.o.	Prague	Czechia
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET	Cherven Bryag	Bulgaria
Medical Center Saint Naum EOOD	Sofia	Bulgaria
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin	Germany
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH	Bad Homburg	Germany
Clintrial s.r.o.	Prague	Czechia
A-Shine s.r.o.	Plzen	Czechia
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Sint-Lucas General Hospital	Brugge	Belgium
Anima	Alken	Belgium
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD	Sofia	Bulgaria
Forbeli s.r.o.	Prague	Czechia
Medical Center Intermedica Ltd.	Sofia	Bulgaria
Spasu Anrn spenvq	Brno-Stred	Czechia
Cwsdyy Ffe Mrmqea Hngmdv Raly Euhn	Ruse	Bulgaria
Edaxuig	Duffel	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	16.07.2024
Bulgaria	Not recruiting	16.07.2024
Czechia	Not recruiting	16.07.2024
Germany	Not recruiting	16.07.2024

Trial locations

BI 1569912 is an experimental medication being tested as an additional treatment for patients with major depressive disorder. The trial aims to find the most effective dose of this medication and to evaluate how well it works in improving symptoms of depression when used alongside other treatments. The study also looks at how well patients tolerate the medication and its safety profile.

Major depressive disorder – Major depressive disorder is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect a person’s thoughts, behavior, and overall well-being. Symptoms may include changes in appetite, sleep disturbances, fatigue, difficulty concentrating, and feelings of worthlessness or guilt. The disorder can vary in severity and duration, with some individuals experiencing recurrent episodes. It often interferes with daily functioning and can impact relationships and work performance. The progression of the disorder can differ from person to person, with some experiencing chronic symptoms and others having periods of remission.

Trial ID:

2023-507942-10-00

Protocol code:

1447-0005

Trial Phase:

Therapeutic exploratory (Phase II)

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Testing BI 1569912 for Major Depressive Disorder in Patients Using Antidepressants

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?