RecruitingNAINTERVENTIONAL

Comorbid Obesity and Depression With an Anti-inflammatory Medication

This study is investigating a new approach to treating depression, especially for people who also have obesity and signs of inflammation in their body. It's looking at a medication called minocycline, which is an antibiotic that might also have anti-inflammatory effects. Researchers believe that some people with depression could benefit from treatments that calm inflammation, particularly those who have both depression and obesity. This study will check if giving minocycline alongside usual antidepressants is practical and acceptable for patients. It will also help us understand if this treatment shows promise in reducing depression symptoms and identifying important body markers for future, larger studies.

At a glance

Status

Recruiting

Phase

Sponsor

King's College London

Enrolment target

Start

01 Oct 2024

Estimated completion

01 Sep 2027

Obesity Major Depressive Disorder Inflammation

What is this study about?

Imagine your body has an internal alarm system, and sometimes this alarm — inflammation — can be overactive. Recent research suggests that for some people, especially those with both obesity and depression, this inflammation might play a role in their depression symptoms. This study is exploring a medication called minocycline, which has been used as an antibiotic but also has properties that can help reduce inflammation.

The main idea is that by calming down this overactive internal alarm, we might be able to help improve depression symptoms. We know that minocycline has shown some promising results in earlier studies for depression. This particular small study is not just about seeing if minocycline works, but also about understanding how easy and acceptable it is for people to take this medication alongside their usual treatments. It will also help us learn if we can measure changes in inflammation in the body during treatment.

Ultimately, the findings from this study will help guide future, larger research efforts. If this approach seems safe, practical, and shows potential, it could open new doors for treating depression in people who also struggle with obesity and inflammation. This is just one step in understanding more about the link between your body's health and your mental well-being.

Key takeaways

This study explores a new way to treat depression, focusing on inflammation.
It's for people with both obesity and depression who show signs of inflammation.
You would take minocycline alongside your usual antidepressant medication.
The study aims to see if this treatment is practical and acceptable for patients.
It's a small, initial study to gather information for future research.

Who may be eligible?

This study is looking for people aged between 18 and 65 who are currently dealing with both obesity and depression. Specifically, you would need to have depression that hasn't fully responded to your current antidepressant treatment, meaning you've tried your medication for at least six weeks and at least one other antidepressant before.

To be considered, blood tests would show you have a certain level of inflammation in your body (CRP greater than 3mg/L), and you'd need to be able to have two MRI scans. You should also be comfortable with adding minocycline to your current medication routine. It's important that you don't plan to change your regular treatment for the duration of the study.

There are also some reasons why you wouldn't be able to join. These include if you have active thoughts of harming yourself, or if you have certain other serious mental health conditions like bipolar disorder or schizophrenia. People with certain serious medical conditions, such as acute infections, some autoimmune diseases, serious heart problems, or neurological disorders like Parkinson's or Alzheimer's, would not be suitable. Additionally, if you're pregnant, breastfeeding, or taking certain medications that could interact with minocycline (like other antibiotics, lithium, or some acne medications), you wouldn't be able to participate.

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?
Do you have both obesity and depression?
Has your depression not fully improved with your current and at least one previous antidepressant?
Are you comfortable having blood tests and two MRI scans?
Are you able to take an additional medication (minocycline) daily for 8 weeks?
Are you not pregnant or breastfeeding, and not taking certain interacting medications?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for 12 weeks. You’ll be asked to take a daily dose of minocycline capsules (200mg) for 8 weeks, alongside your regular antidepressant medication. You won't be able to change your current antidepressant during this time.

Throughout the 12 weeks, you'll have several visits to the clinic. These visits will involve blood and saliva tests to measure signs of inflammation and other body markers. You’ll also need to have two MRI scans of your brain. To help us understand how you're feeling, you'll complete questionnaires and have some interviews. Your feedback on your experience in the study will be very important.

We'll also keep track of things like how many people join and stay in the study, and how easy or difficult they find the different tests and procedures. This will help us plan larger studies in the future.

Potential risks and benefits

Taking part in this study could offer the potential benefit of trying a new approach to managing your depression, which might help reduce your symptoms, especially if your body shows signs of inflammation. However, it's also important to be aware of potential risks. Minocycline, like all medications, can have side effects. These can include stomach upset, dizziness, and increased sensitivity to sunlight. There is also a rare possibility of more serious side effects, and risks associated with MRI scans. Before you decide, the study team will explain all known side effects and risks in detail. Remember, your participation is voluntary, and 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.

King's College London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is inflammation, and why does it matter for depression?

Inflammation is your body's natural response to injury or infection. Recent research suggests that long-term, low-level inflammation might play a role in some people's depression, particularly those who also have obesity.

What is minocycline, and is it a new drug?

Minocycline is actually an older antibiotic. However, scientists are now exploring its potential to help reduce inflammation in the body, which might offer a new way to treat certain types of depression.

Will I have to stop my current depression medication?

No, you will continue taking your usual antidepressant medication alongside the minocycline. This study looks at adding minocycline to your existing treatment.

What is a 'feasibility' study?

A feasibility study is a small, early-stage study designed to see if a new treatment approach is practical, safe, and acceptable to patients, before launching into a much larger trial.

What does a 'treatment-resistant' depression mean?

It means your depression hasn't fully improved after trying at least two different antidepressant treatments for a reasonable amount of time.

How to find out more

Valeria Mondelli

valeria.mondelli@kcl.ac.uk +442078480353 Official trial record

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