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Study on the Effects of Minocycline on Inflammation in Patients with Depression

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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 the effects of the medication Minocycline on patients with Depression. Depression is a common mental health condition that affects mood and overall well-being. The study aims to see if Minocycline can help reduce inflammation in the body, which is thought to be linked to depression. Minocycline is an antibiotic that is being tested for its potential benefits beyond treating infections.

The purpose of the study is to evaluate whether Minocycline can improve the inflammatory status in patients with depression when added to their current treatment. Participants will receive Minocycline for a period of eight weeks. During this time, researchers will monitor changes in inflammation levels and depressive symptoms. The study will also use imaging techniques like PET and MRI to observe any changes in the brain's structure and function.

Throughout the study, participants will continue their usual depression treatment while taking Minocycline. The researchers will assess the effects of the medication by comparing inflammation and depression symptoms before and after the treatment period. This study hopes to provide insights into how Minocycline might help manage depression by targeting inflammation.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of major depressive disorder and ensuring stability on current antidepressant therapy for at least 8 weeks.
Eligibility criteria include being aged 18-60, having a nonpsychotic major depressive disorder, and being a non-responder to a current SSRI (a type of antidepressant) for at least 8 weeks.
Step 2
Informed consent
Participants are required to sign and date an informed consent form, indicating their understanding and agreement to participate in the study.
Step 3
Baseline measurements
Baseline measurements are taken to assess the current levels of peripheral inflammatory biomarkers and depressive symptoms.
These measurements may include blood tests and imaging studies such as PET and MRI scans.
Step 4
Treatment phase
Participants begin an 8-week treatment with Minocycline, in addition to their current antidepressant medication.
Minocycline is administered in the form of 100 mg capsules, taken orally. The frequency and specific dosage schedule are determined by the study protocol.
Step 5
Follow-up assessments
Throughout the 8-week treatment period, regular follow-up assessments are conducted to monitor changes in inflammatory biomarkers and depressive symptoms.
These assessments may include additional blood tests and imaging studies to evaluate any changes in brain structure and function.
Step 6
Final evaluation
At the end of the 8-week treatment period, a final evaluation is conducted to assess the overall impact of Minocycline on inflammation and depressive symptoms.
The study aims to identify any associations between changes in inflammation, brain activity, and improvements in depressive symptoms.

Who can join the trial?

10 criteria

Must be a male or female patient aged between 18 and 60 years old.
Must have a current diagnosis of **major depressive disorder** without psychotic features, confirmed by a structured interview called **SCID**.
Must not have responded to a current **SSRI** (a type of antidepressant) for at least 8 weeks, and also not have responded to another SSRI in the past.
Must have been on a stable antidepressant treatment for at least 8 weeks.
Must be able to tolerate the current SSRI medication.
Must agree to receive treatment with **Minocycline** (an antibiotic that may help with inflammation).
Must have a **CRP level** greater than 2 mg/L. CRP is a protein in the blood that increases with inflammation.
Must have signed and dated a form agreeing to participate in the study.
Must not have any medical reasons that would prevent taking Minocycline.
Must not have any medical reasons that would prevent undergoing a **11C-PK PET scan**, which is a type of imaging test.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with depression cannot participate. Depression is a mental health condition that affects mood and behavior.
Patients who are not within the specified age range cannot participate. The age range for this study is 18 to 65 years old.
Patients who are not currently receiving pharmacological treatment for depression cannot participate. Pharmacological treatment refers to medication prescribed by a doctor to help manage depression.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have additional risks or require special protection in research.

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Verified sites

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Universita Degli Studi Di Brescia
Brescia, Italy

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Investigated drugs

Minocycline is an antibiotic that is being studied for its potential to reduce inflammation in patients with depression. In this trial, it is used alongside the patient's current depression medication to see if it can improve their inflammatory status, which may be linked to their depression symptoms.

Minocycline Hydrochloride

What is already known about the treatment

Minocycline – Minocycline is administered orally in the form of tablets or capsules. It is currently being studied for its potential use in treating depression, particularly in patients with inflammation-related symptoms. The main therapeutic indication being explored is its ability to improve inflammatory status in depressed patients. At the molecular level, Minocycline works by inhibiting certain enzymes and reducing inflammation, which may help alleviate depressive symptoms. It is classified as a tetracycline antibiotic, but its anti-inflammatory properties are being investigated for new therapeutic uses.

Investigated diseases

Depression – Depression is a mental health disorder characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect how a person thinks, feels, and handles daily activities. Symptoms may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The condition can vary in severity and duration, with some individuals experiencing recurrent episodes. Depression is often associated with changes in brain chemistry and function. It can also be linked to physical symptoms, such as aches and pains, and may impact social and occupational functioning.