Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

TSPO ligands in the treatment of depression: proof-of-concept of efficacy and underlying mechanisms of action

This research is looking into a new treatment for depression, including both unipolar and bipolar types. The treatment comes as a capsule and researchers are trying to see if it helps people feel better. They also want to understand the way this treatment works inside the body. This is an early stage (Phase II) clinical trial, which means they are checking for the treatment's effectiveness and safety in a small group of people for the first time. The study will involve regular check-ups to measure changes in mood and other body markers over about a month. It's open to adults aged 18 and over, of any gender.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medizinische Einrichtungen des Bezirks Oberpfalz KU AöR

Enrolment target

Start

25 Jul 2024

Unipolar/bipolar depressive disorder

What is this study about?

This study is exploring a new potential treatment for people who experience depression, specifically those with unipolar or bipolar depressive disorder. The treatment is given as a hard capsule, and the researchers want to find out two main things: first, if it helps to improve symptoms of depression, and second, how it affects the body and brain at a deeper level. This kind of research is important because it helps us discover new ways to help people living with depression.

Learning how a treatment works is just as important as knowing if it helps. By understanding the body's response, scientists can sometimes develop even better treatments in the future. This particular study is in an early stage, which is called Phase II. This means it's one of the first times the treatment is being tested in a small group of people to see if it's effective and safe enough to continue with further, larger studies.

Participants will receive either the active treatment or a placebo, which looks identical but doesn't contain the active medicine. This allows researchers to accurately compare how well the new treatment works against no treatment. Regular check-ups will help track any changes in your mood and other health markers during the study period.

Key takeaways

This study is testing a new capsule treatment for depression.
It's for adults with unipolar or bipolar depressive disorder.
Researchers want to see if the treatment helps and how it works.
Participants will take a capsule and attend regular check-ups for about a month.
You might receive the active treatment or a placebo (dummy pill).

Who may be eligible?

To take part in this study, you need to be an adult, meaning you are 18 years old or older. The study is open to both men and women.

You must have been diagnosed with either unipolar (also known as major depression) or bipolar depressive disorder. The researchers are specifically looking for people with these conditions to see how the new treatment affects them.

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?
Have you been diagnosed with unipolar depression?
Have you been diagnosed with bipolar depressive disorder?
Are you able to take a capsule by mouth?
Are you willing to attend regular study appointments for about a month?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given a capsule to take by mouth. You won't know if it's the active medicine or a 'dummy' pill (called a placebo), which looks exactly the same. You'll have several visits to the study clinic over about a month. These visits will involve answering questions about your mood and feelings (using questionnaires), and possibly having some blood tests, saliva samples, and brain scans (fMRI). You might also do some tests on a computer to check your thinking skills.

Your mood and health will be closely monitored, with assessments on most days during the first week, and then less frequently over the rest of the month. You'll be asked about any side effects you might experience. The total length of the study from start to finish will be approximately 29 days.

Potential risks and benefits

Taking part in this study *may* offer some potential benefits. You might find that the new treatment helps improve your depressive symptoms. You'll also receive careful monitoring of your health and mood throughout the study. However, like all medicines, there could be potential risks or side effects that are not yet fully known. You might experience side effects from the capsule, or it might not help your condition. Importantly, you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What kind of depression is this study for?

This study is for people diagnosed with either unipolar depression or bipolar depressive disorder.

What will I have to take?

You will be given a capsule to take by mouth. It will either contain the active medicine or a look-alike dummy pill (placebo).

How long will the study last?

The study will last for approximately 29 days, with several check-up visits during that time.

Will I know if I'm getting the real medicine?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're receiving the active medicine or the placebo.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point, with no questions asked, and it won't affect your regular medical care.