AuthorisedTherapeutic exploratory (Phase II)Interventional

Targeting inflammation in depression using Minocycline: a patient stratification approach using peripheral inflammatory biomarkers and MRI

This study, called 'Targeting inflammation in depression using Minocycline,' aims to understand if an antibiotic called Minocycline can help people with depression. Some research suggests that inflammation in the body might play a role in depression. Participants will take Minocycline capsules for eight weeks. Before and after treatment, researchers will take blood samples to check for signs of inflammation and use special brain scans (MRI) to look at brain changes. They'll also carefully track any improvements in mood. The goal is to see if reducing inflammation can improve depression and if body inflammation levels can help doctors choose the best treatment for individual patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli

Enrolment target

100

Start

03 Feb 2025

Depression

What is this study about?

This research study is looking into a new way to help people with depression. It's called 'Targeting inflammation in depression using Minocycline.' The main idea behind this study is that for some people, inflammation in the body might be connected to their depression. Inflammation is your body's natural response to injury or infection, but sometimes it can become a long-term problem.

Researchers are using a common medicine called Minocycline, which is an antibiotic often used to treat infections like acne. However, Minocycline also has properties that can help reduce inflammation. The study wants to find out if taking Minocycline for eight weeks can lower inflammation markers in the blood of people with depression and, if so, whether this also helps improve their mood and symptoms of depression.

During the study, participants will have blood tests to measure inflammation before and after taking Minocycline. They will also have brain scans using an MRI machine. This helps researchers see if there are any changes in the brain that might be linked to the treatment. By understanding these connections, the study hopes to find out if measuring inflammation in the blood could help doctors decide if Minocycline is a good treatment option for certain individuals with depression.

Key takeaways

This study investigates if the antibiotic Minocycline can help depression.
It aims to see if reducing body inflammation improves mood.
Participants will take Minocycline for 8 weeks.
Blood tests and brain scans (MRI) will track changes.
The study hopes to find better ways to choose depression treatments.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 years and older who have been diagnosed with depression. Both men and women are welcome to take part.

To be considered for the study, you would need to meet certain health criteria that the research team will explain. This is to make sure the study is safe for you and that the results are clear.

It's important to discuss any current health conditions or medicines you are taking with the study team. They will carefully check if this study is the right fit for you.

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 depression?
Are you comfortable with blood tests?
Are you able to have an MRI brain scan?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given Minocycline capsules to take for eight weeks. Throughout this period, you will have regular visits to the clinic.

Before you start treatment, and again after eight weeks, you will have blood tests to measure inflammation markers. You will also have special scans of your brain, called an MRI, at these times. The study team will ask you questions about your mood and how you are feeling to track any changes in your depression symptoms.

After the eight weeks of treatment are over, the researchers will continue to follow up with you. This involves checking in at 12 weeks and 32 weeks from when you first started the study (which is about 4 and 24 weeks after finishing the Minocycline) to see how you are doing. The total duration of your active involvement in the study, including follow-up, will be around 32 weeks.

Potential risks and benefits

Taking part in a study like this may have potential benefits, such as receiving a potential new treatment for depression and contributing valuable information that could help others in the future. As with any medicine, Minocycline has potential side effects, which the study team will discuss with you in detail. There are also potential risks associated with blood tests and MRI scans, but these are generally considered safe procedures. You have the right 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
Italy

Common questions

What is Minocycline?

Minocycline is an antibiotic often used to treat infections. This study is exploring if it can also help with depression by reducing inflammation.

What is inflammation and how is it linked to depression?

Inflammation is your body's way of fighting off harm. Some research suggests that ongoing inflammation in the body might play a role in depression for certain people.

Will I definitely get Minocycline?

Yes, all participants in this particular study will receive Minocycline capsules for 8 weeks.

What is an MRI scan?

An MRI (Magnetic Resonance Imaging) is a safe and painless scan that uses strong magnets and radio waves to create detailed pictures of the inside of your body, in this case, your brain.

How long will I be involved in the study?

You will take the medicine for 8 weeks, and then have follow-up checks for about 24 more weeks, making the total involvement roughly 32 weeks.