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Study on Celecoxib for Reducing Symptoms in Adults with Major Depressive Disorder and Immuno-metabolic Characteristics

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Major Depressive Disorder, a condition characterized by persistent feelings of sadness and loss of interest. The study is exploring the effects of an anti-inflammatory medication called Celecoxib, which is typically used to relieve pain and inflammation. Participants in the study will receive either Celecoxib or a placebo to determine if Celecoxib is more effective in reducing symptoms of depression when added to their usual treatment, which may include medication or therapy.

The purpose of the study is to evaluate whether a 12-week treatment with Celecoxib, taken orally at a dose of 400 mg per day, can help reduce depressive symptoms more effectively than a placebo. The study will last for 12 weeks, during which participants will continue their regular treatment for depression. The study aims to see if Celecoxib can improve symptoms such as low energy and mood, which are common in people with depression.

Participants will be monitored throughout the study to assess changes in their symptoms and overall well-being. The study will also look at other factors like fatigue, sleep, anxiety, and any side effects experienced. By the end of the study, researchers hope to better understand the potential benefits of using Celecoxib as an additional treatment for people with Major Depressive Disorder.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the trial's purpose and procedures.
You will undergo a clinical interview to confirm your diagnosis of major depressive disorder. This is done using a structured interview called MINI.
Step 2
Initial assessment
You will complete the Inventory of Depressive Symptomatology (IDS), a questionnaire with 30 items to assess your depressive symptoms.
Your blood will be tested to measure CRP levels, which is a marker of inflammation in the body.
Step 3
Medication phase
You will be randomly assigned to receive either Celecoxib or a placebo. Celecoxib is an anti-inflammatory medication given in a dose of 400 mg per day, taken orally in the form of hard capsules.
This phase lasts for 12 weeks, during which you will continue your usual treatment, which may include medication or therapy.
Step 4
Follow-up assessments
Throughout the 12-week period, you will regularly complete the IDS questionnaire to monitor changes in your symptoms.
Additional assessments will include evaluating fatigue, food cravings, sleep patterns, anxiety symptoms, and overall functioning.
Step 5
End of trial
At the end of the 12 weeks, a final assessment will be conducted to evaluate your response to the treatment.
Your blood will be tested again to check for changes in CRP and other markers.

Who can join the trial?

7 criteria

Age between 18 and 65 years.
Have a diagnosis of Major Depressive Disorder (MDD), confirmed through a clinical interview.
Currently receiving treatment with medication (such as antidepressants like SSRI, SNRI, TCA, TetraCA, MAOI, bupropion, vortioxetine, agomelatine) and/or psychotherapy. You should have been on your current treatment for at least 4 weeks.
Have a score of 26 or higher on the Inventory of Depressive Symptomatology (IDS), and a score of 6 or higher on the scale for atypical, energy-related symptoms from the IDS.
Have a CRP (C-reactive protein) level greater than 1 mg/L. CRP is a substance in the blood that can indicate inflammation.
If you are a female participant, you must not be pregnant or breastfeeding. If you are of childbearing potential, you must agree to use a contraceptive method during the study and for 1 month after the study.
Provide signed informed consent, which means you agree to participate in the study after understanding all the details and risks involved.

Who cannot join the trial?

5 criteria

Patients who do not have a diagnosis of Major Depressive Disorder cannot participate.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who do not have atypical, energy-related symptoms (such as feeling very tired) cannot participate.
Patients who do not have a CRP level (a blood test marker for inflammation) greater than 1 mg/L cannot participate.
Patients who are part of a vulnerable population (such as those unable to give consent) cannot participate.

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Verified sites

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Celecoxib is a medication that is being tested in this clinical trial to see if it can help reduce symptoms of depression. It is known as an anti-inflammatory drug, which means it works by reducing inflammation in the body. Inflammation has been linked to depression, especially in people who have certain types of depression with symptoms like low energy. The trial is exploring whether adding celecoxib to the usual treatments for depression, such as therapy or other medications, can make these treatments more effective for people with major depressive disorder.

Celecoxib

What is already known about the treatment

Celecoxib – Celecoxib is administered orally in the form of capsules. It is currently being studied in clinical trials for its potential use in treating major depressive disorder, particularly in cases with specific inflammatory and metabolic characteristics. The main therapeutic indication being explored is its ability to reduce depressive symptoms when added to standard treatments like medication and therapy. At the molecular level, celecoxib works by inhibiting an enzyme called COX-2, which plays a role in inflammation, potentially reducing inflammation-related symptoms in depression. It is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Investigated diseases

Major Depressive Disorder – Major Depressive Disorder is a mental health condition characterized by persistent and intense feelings of sadness and loss of interest in activities once enjoyed. It affects how a person feels, thinks, and handles daily activities, such as sleeping, eating, or working. The disorder progresses with episodes that can last for weeks or months, where individuals may experience a range of symptoms including fatigue, changes in appetite, and difficulty concentrating. Over time, these symptoms can become more severe, impacting personal and professional life. The disorder can also manifest with physical symptoms such as pain or digestive issues. It is important to note that the intensity and duration of symptoms can vary widely among individuals.