Study on Minocycline and Celecoxib for Patients with Major Depressive Disorder Not Responding to Antidepressants

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What is this study about?

This clinical trial is focused on studying Major Depressive Disorder (MDD), a condition characterized by persistent feelings of sadness and loss of interest. The study aims to evaluate the effectiveness of two medications, Minocycline and Celecoxib, in patients who have not responded to one or two previous antidepressant treatments. Minocycline is typically used as an antibiotic, while Celecoxib is commonly used to relieve pain and inflammation. Both medications will be tested to see if they can help improve symptoms of depression when added to the current treatment regimen.

Participants in the study will be randomly assigned to receive either Minocycline, Celecoxib, or a placebo, which is a substance with no active medication. The study will last for a period of 12 weeks, during which participants will take the assigned medication orally. Throughout the study, participants will be monitored to assess changes in their depression symptoms and overall health. The goal is to determine if these medications can provide additional benefits for those with MDD who have not found relief with standard antidepressant treatments.

The study will also look at various health markers, such as sleep quality, anxiety levels, and metabolic health, to understand the broader effects of the medications. By the end of the study, researchers hope to gather valuable information on whether Minocycline or Celecoxib can be effective additions to the treatment of Major Depressive Disorder, potentially offering new options for those who struggle with this challenging condition.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of the current health status and a diagnosis of Major Depressive Disorder (MDD) using specific criteria.

A score of 14 or higher on the Hamilton Depression Rating Scale (HDRS-17) is required. This scale measures the severity of depression symptoms.

2 baseline measurements

Baseline measurements will be taken, including depression severity, sleep quality, anxiety levels, and metabolic health indicators such as body mass index (BMI) and cholesterol levels.

These measurements will help track changes throughout the study.

3 medication administration

Participants will be randomly assigned to receive either Minocycline (100 mg film-coated tablet) or Celecoxib (200 mg hard capsule), or a placebo. These medications are taken orally.

The medication will be administered daily for a duration of 12 weeks.

4 regular follow-up visits

Regular follow-up visits will be scheduled to monitor progress and any side effects. These visits will occur periodically over the 12-week period.

During these visits, assessments similar to the baseline measurements will be repeated to evaluate changes in depression severity and other health indicators.

5 final assessment

At the end of the 12-week period, a final assessment will be conducted. This will include a comprehensive evaluation of depression severity and other health outcomes.

The primary goal is to measure any changes in the HDRS-17 score and determine the rates of remission.

Who Can Join the Study?

Must be a male or female aged between 18 and 65 years.
Must be able and willing to give informed consent and take oral medication.
Must be physically healthy.
Must have a diagnosis of Major Depressive Disorder (MDD) confirmed by a specific interview called the Mini International Neuropsychiatric Interview (MINI).
The current episode of depression must have failed to improve with the current antidepressant treatment at the right dose. If the depression returned while on an antidepressant, it is also considered a treatment failure.
Must be tolerant to the current antidepressant and have no planned changes in their current therapy for the duration of the study.
Must be stable on current treatment for at least 4 weeks (or 6 weeks for the medication fluoxetine) before starting the study.
If female and of childbearing age, must be willing to use adequate contraceptive precautions and take pregnancy tests.
Must have a score of 14 or higher on the Hamilton Depression Rating Scale (HDRS-17), which is a questionnaire used to measure the severity of depression.

Who Cannot Join the Study?

Patients who do not have Major Depressive Disorder (MDD) cannot participate.
Patients who have not tried at least one or two antidepressant treatments without success cannot participate.
Patients who are not within the age range specified for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Vrije Universiteit Brussel	Jette	Belgium
SINAPS	Duffel	Belgium
Ukmmigpmjj Oj Ahgjunw	Duffel	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Minocycline is an antibiotic that is commonly used to treat infections. In this clinical trial, it is being used for a different purpose. Researchers are exploring whether minocycline can help reduce inflammation in the brain, which might improve symptoms in people with major depressive disorder (MDD) who have not responded well to standard antidepressant treatments. The idea is that by reducing inflammation, minocycline might help improve mood and other symptoms of depression.

Celecoxib is a medication that is usually used to relieve pain and inflammation in conditions like arthritis. In this trial, celecoxib is being tested to see if it can help people with major depressive disorder who have not had success with typical antidepressant medications. The researchers believe that by targeting inflammation, celecoxib might help improve the symptoms of depression, offering a new approach for those who have not found relief with other treatments.

Investigated diseases:

Major depression

Major Depressive Disorder (MDD) – Major Depressive Disorder is a mental health condition characterized by persistent and intense feelings of sadness and despair. It affects how a person feels, thinks, and handles daily activities, such as sleeping, eating, or working. The disorder often involves a loss of interest or pleasure in activities once enjoyed. Symptoms can include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The progression of MDD can vary, with some individuals experiencing episodes that last for weeks or months. Over time, these episodes can become more frequent or severe if not addressed.

Trial ID:

2022-501692-35-00

Protocol code:

INSTA-MD

NCT ID:

NCT05644301

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Minocycline and Celecoxib for Patients with Major Depressive Disorder Not Responding to Antidepressants

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?