Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II, 6-week, multi-centre, randomised, double-blind (participant and investigator), placebo-controlled, dose-finding trial to evaluate the efficacy, tolerability, and safety of different doses of oral BI 1569912 as adjunctive therapy in patients with major depressive disorder

This study is testing a new medication, called BI 1569912, for adults experiencing major depression. It's a phase II study, meaning researchers are trying to find the best dose and see how well it works and if it's safe. Participants will be randomly assigned to receive either the new drug or a dummy pill (placebo) alongside their current depression treatment. Neither the patient nor the doctor will know who is getting the new drug. Researchers will measure changes in depression symptoms over six weeks, looking at how much symptoms improve and if people feel better overall. The main goal is to see if the new drug significantly reduces depression symptoms.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

02 Jul 2024

Major depressive disorder

What is this study about?

When someone has major depression, it can be a really tough time, affecting mood, sleep, appetite, and how they generally feel about life. While there are treatments available, sometimes people need extra help to feel better. This study is exploring a new medication, called BI 1569912, that could potentially be added to a person's existing treatment for depression.

The main aim is to carefully examine if this new medication can help reduce the symptoms of depression and if it's safe for people to take. Researchers will be comparing different doses of the new drug against a "dummy pill" (which contains no active medicine). This helps them understand whether the drug itself is making a difference.

This is a 'Phase II' study, which means it's an earlier stage of research. Scientists are focused on finding the right dose of the drug and getting a clearer picture of how effective it is and what side effects might occur. The study will last for six weeks, during which participants will be closely monitored to see how their depression symptoms change.

Key takeaways

This study is testing a new drug for major depression.
It aims to find the right dose and check its safety and effectiveness.
Participants will receive the new drug or a dummy pill alongside their usual medication.
The study lasts for six weeks, with regular check-ups.
It's a 'Phase II' study, an earlier stage of drug development.

Who may be eligible?

To be able to take part in this study, you would need to be an adult, aged 18 years or older. Both men and women are welcome to participate.

The most important thing is that you have a diagnosis of major depressive disorder. This study is specifically designed for people who are currently experiencing this condition and are seeking new ways to manage their symptoms.

There might be other health conditions or medications that would prevent someone from joining, as the researchers need to make sure the study is safe and that the results are clear. Your doctor will be able to check all the specific details.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of major depressive disorder?
Are you currently receiving treatment for your depression?
Are you able to attend regular clinic appointments for six weeks?
Are you generally in good health, apart from your depression?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several visits to a clinic over a six-week period. During these visits, you would have your health checked, discuss your symptoms, and potentially complete some questionnaires about how you are feeling. You would be given the study medication, which would be either the new drug (BI 1569912) or a placebo (a dummy pill), to take alongside your current depression treatment. Neither you nor the study doctor would know which you are receiving – this is a common practice to ensure fair results. Your progress would be monitored closely throughout the six weeks to see how your symptoms change.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the new medication might help to relieve your depression symptoms more effectively than your current treatment alone. However, there's no guarantee, and you might receive the placebo (dummy pill) which has no active medicine. As with any medication, there's a chance of experiencing side effects, which the study team will monitor very carefully. You will be given full details of known side effects before you decide to join. It is very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium
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Unverified
Bulgaria
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Unverified
Czechia
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Unverified
Germany

Common questions

What is 'major depressive disorder'?

Major depressive disorder, often simply called depression, is a mood disorder that causes a persistent feeling of sadness and loss of interest. It can affect how you feel, think, and behave, and can lead to a variety of emotional and physical problems.

What does 'adjunctive therapy' mean?

Adjunctive therapy means the new medication (BI 1569912) would be taken in addition to your current depression treatment, not instead of it. It's like an 'add-on' to see if it can boost the effects of what you're already taking.

What is a 'placebo' and why is it used?

A placebo is a 'dummy' pill that looks just like the study drug but contains no active medicine. It's used so researchers can fairly compare how much the real drug helps compared to just the act of taking a pill, without anyone knowing which they are receiving until the end of the study.

Will I know if I'm getting the new drug or the placebo?

No, you won't know, and neither will your study doctor. This is called 'double-blind' and is done to make sure the results are as unbiased and accurate as possible. Only after the study has finished will this information be revealed.

How long will the study last if I join?

The main treatment period for this study is six weeks. You would have visits to the clinic throughout this time for monitoring and assessments.