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RecruitingTherapeutic confirmatory (Phase III)Interventional

Precision psychiatry: Anti-inflammatory medication in Immuno-metabolic depression

Major depression can affect both the mind and the body. Scientists believe that in some people, swelling or immune activity in the body—known as inflammation—might play a part in causing depression symptoms. This study is testing an anti-inflammatory medicine called celecoxib to see if it can relieve depression linked to physical health factors. The trial lasts 12 weeks. Participants will be randomly chosen to take either a 200 mg celecoxib capsule once a day or a dummy capsule called a placebo. During the study, doctors will track your mood, energy levels, sleep quality, and food cravings. They will also carry out simple blood tests to see if body inflammation decreases. The study aims to help doctors choose more targeted treatments for people with depression in the future.

At a glance

Status
Recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Amsterdam UMC Stichting
Enrolment target
140
Start
11 Oct 2024

What is this study about?

Depression is a common condition that causes low mood, lack of energy, and loss of interest in daily life. For many years, treatments have focused mainly on brain chemicals. However, doctors now know that the immune system and metabolism also play an important role. When the body's immune system stays active for too long, it causes persistent swelling known as inflammation. In some people, this inflammation seems to trigger or worsen depressive symptoms like extreme fatigue and changes in appetite.

This trial is testing whether an anti-inflammatory medicine called celecoxib can help people with this specific type of depression. Celecoxib is already used safely to treat pain and joint swelling in conditions like arthritis. Researchers want to find out if cooling down inflammation in the body can also lift mood, improve sleep, and restore energy.

Finding targeted treatments is a key goal in modern mental health care. If this study is successful, it could help doctors identify which patients are most likely to benefit from anti-inflammatory treatments, offering a helpful new path for people whose depression has not fully responded to usual care.

Key takeaways

  • Tests whether an anti-inflammatory drug (celecoxib) helps treat major depression.
  • Compares the active medicine against a dummy pill (placebo) over 12 weeks.
  • Open to adults aged 18 and older diagnosed with depression.
  • Involves questionnaires about mood and fatigue, plus routine blood tests.
  • Taking part is voluntary, and you can withdraw at any point.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with major depressive disorder. It focuses especially on people whose depression may be linked to bodily changes, such as low energy, sleep issues, or increased inflammation.

Both men and women can join. Because the study looks at how inflammation and metabolism affect mood, doctors will review your general physical and mental health to check if this study is suitable and safe for you.

You may not be able to join if you have certain other medical conditions, allergies to anti-inflammatory medicines, or if you are taking medications that cannot be safely combined with celecoxib. The study team will explain these rules in detail before you decide to take part.

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.

  1. I am aged 18 or older.
  2. I have a diagnosis of major depressive disorder.
  3. I experience symptoms like low energy, sleep issues, or fatigue.
  4. I am able to attend clinic visits and take a daily capsule for 12 weeks.
  5. I am willing to have routine blood tests and answer health surveys.
Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for about 12 weeks. If you choose to join, you will be placed into one of two groups by chance. One group takes a daily 200 mg celecoxib capsule, and the other group takes a matching dummy pill (placebo). Neither you nor your doctor will know which pill you are taking until the study ends.

You will attend regular check-ups with the study team. At these visits, you will fill out questionnaires about your mood, energy, sleep, appetite, and any aches or pains. The team will also check your blood pressure and take routine blood samples to measure inflammation and cholesterol levels. These visits give the researchers a clear picture of how you are feeling and ensure your safety throughout the 12 weeks.

Potential risks and benefits

A potential benefit is that you might see an improvement in your low mood and physical symptoms, although this cannot be guaranteed. You will also receive thorough medical monitoring, and your involvement will help scientists understand better ways to treat depression. The risks include possible side effects from celecoxib, such as mild stomach upset, indigestion, or headaches. There is also a chance you will receive the dummy pill, which contains no active medicine. Joining is completely your choice, and you can change your mind and leave the trial at any time without your regular NHS care being affected.

Locations (1)

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

Common questions

What is celecoxib?

Celecoxib is a medicine that reduces swelling and pain. It is widely used to treat joint pain and arthritis.

What is a placebo?

A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. It helps researchers test if the drug truly works.

Can I choose whether I get the real drug or the dummy pill?

No. A computer randomly assigns you to a group to make sure the trial results are fair and unbiased.

Can I carry on taking my current antidepressant?

Often yes, but this depends on your exact medication. The study team will review what you are taking to make sure it is safe.

What happens if I feel worse during the study?

Your safety comes first. The study team monitors your mood closely and will step in to support you or adjust your care if needed.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Precision psychiatry: Anti-inflammatory medication in Immuno…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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