RecruitingNAINTERVENTIONAL

Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation

This study explores a new way to understand and treat depression, particularly for people who also have internal body inflammation. Scientists believe that inflammation might affect how our brains use dopamine, a chemical important for motivation and movement. We're testing a common medication, similar to L-dopa/Carbidopa, to see if boosting dopamine can help improve common symptoms of depression like feeling unmotivated or having slower movements. The study involves people with major depression and healthy volunteers, using a carefully designed method where some receive the study drug and others a dummy pill, without anyone knowing which they're getting. If successful, this research could pave the way for new treatments for depression that specifically target inflammation-related symptoms.

At a glance

Status

Recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

165

Start

26 Jul 2023

Estimated completion

01 Jul 2026

Depressive Disorder, Major

What is this study about?

Many people with depression experience challenges with motivation and physical energy. These symptoms, like feeling unable to do things or moving more slowly, might be linked to inflammation within the body. When your body is inflamed, it can affect important brain chemicals, like dopamine, which plays a key role in how we feel motivated and how we move. This study aims to investigate this connection.

We are looking into whether giving a medication that boosts dopamine could help improve motivation and movement difficulties in people with major depression, especially when inflammation is present. We will compare this treatment to a 'dummy' pill (placebo) in a way that neither the participants nor the researchers know who is getting which. This helps us get clearer results.

Ultimately, if this study is successful, it could provide important information showing that medicines that increase dopamine might be an effective new treatment option for depression, particularly for those whose symptoms are linked to inflammation.

Key takeaways

Exploring if a dopamine-boosting medicine can help depression symptoms linked to inflammation.
Specifically targets motivation and movement difficulties in depression.
Compares a study drug to a dummy pill (placebo).
Aims to find new treatment options for specific types of depression.
Participation is voluntary and carefully monitored.
Could help us understand the role of inflammation in depression better.

Who may be eligible?

You might be able to take part if you are between 18 and 65 years old. For those with major depression, you would need to have received a diagnosis of major depressive disorder and not currently be taking antidepressant medication.

If you are a healthy volunteer, you would need to have certain normal blood test results (specifically, a C-reactive protein level below 1 mg/l), not be on antidepressant medication, and not have any current mental health conditions. We are looking for people who are generally healthy, without certain medical problems that could interfere with the study or make participation unsafe.

There are some reasons you wouldn't be able to join, such as if you have certain other mental health conditions (like bipolar disorder or schizophrenia), a history of severe health issues (like certain heart conditions, uncontrolled asthma, severe obesity, or current infections), or if you are pregnant or breastfeeding. Also, if you're taking specific kinds of medications that could react with the study drug, you wouldn't be eligible. The research team will discuss all these details with you carefully.

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 between 18 and 65 years old?
If you have depression, are you currently not taking antidepressant medication?
Do you have a diagnosis of major depressive disorder?
Do you have a personal history free from bipolar disorder, schizophrenia, or severe drug/alcohol dependence?
Are you generally healthy, without severe ongoing medical conditions?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

The study involves a series of visits to the clinic. During these visits, you will undergo tests to measure your motivation, movement, and inflammation levels. You will receive either the study medication or a placebo (a dummy pill) for a set period. Because this is a crossover study, you might switch during the study to receive the other treatment (either the study medication or the placebo). You won't know which one you are taking at any given time, nor will the study team. You'll need to take the medication as directed and attend all scheduled appointments. We will regularly check in with you to monitor your health and any effects of the medication. The total duration of your participation in the study will be explained in full by the research team.

Potential risks and benefits

Taking part in this study could potentially offer benefits by helping us understand how dopamine and inflammation affect depression, which might lead to better treatments in the future. You may or may not personally experience an improvement in your symptoms. There are potential risks, including side effects from the study medication, though these will be carefully monitored. You will receive a full explanation of all known risks before you decide to participate. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Klinik für Psychiatrie und Psychotherapie
Verified postcode
Steglitz, Germany· Recruiting

Common questions

What is dopamine and why is it important?

Dopamine is a natural chemical in your brain that helps with motivation, pleasure, and movement. It's often linked to how we feel energetic and driven.

What does 'inflammation' mean in this study?

Here, inflammation refers to processes inside your body that can sometimes be related to illness or stress. In depression, signs of inflammation can affect how your brain works.

What is a 'placebo'?

A placebo is a 'dummy pill' that looks like the study medication but does not contain any active ingredients. It helps us see if the actual medicine is having an effect or if improvements are due to other factors.

Will I know if I'm getting the actual medication or the placebo?

No, neither you nor the study team will know which you are receiving during the study. This is called 'double-blind' and helps make the study results more reliable.

What happens if I want to stop participating?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Woo Ri Chae, MD MSc

woo-ri.chae@charite.de +49 30 450 517625 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.