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Testing BI 1569912 for Major Depressive Disorder in Patients Using Antidepressants

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

5 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

BI 1569912 – This medication is administered orally and is currently being studied in clinical trials as an adjunctive therapy for major depressive disorder. It is in the experimental phase, specifically a Phase II trial, which aims to determine its efficacy, tolerability, and safety at different doses. The main therapeutic indication is for major depressive disorder, where it is intended to be used alongside other treatments. The mechanism of action at the molecular level is not fully detailed in the provided data, but it is being evaluated for its potential effects on mood regulation. It falls under the pharmacological classification of antidepressants, although its specific subclass is not specified in the trial data.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507942-10-00Protocol code1447-0005Estimated enrolment222 patientsSponsorBoehringer Ingelheim International GmbH

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