Study on Brain Inflammation in Patients with Major Depressive Disorder Using 18F-DPA-714

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What is this study about?

This clinical trial is focused on understanding brain inflammation in people experiencing a major depressive disorder (MDD). The study uses a special imaging technique to observe brain activity and inflammation. The treatment being studied involves a solution for injection called 18F-DPA-714, which is a chemical substance used to help visualize inflammation in the brain. This substance is injected into the bloodstream and helps highlight areas of inflammation during imaging tests.

The purpose of the study is to compare brain inflammation patterns among three groups: those currently experiencing MDD, those who have had MDD but are in remission and still taking antidepressants, and healthy individuals without any history of depression. Participants will undergo imaging tests to observe the distribution of inflammation in the brain. The study aims to provide insights into how inflammation is related to depression and how it differs between those currently experiencing depression, those in remission, and healthy individuals.

Throughout the study, participants will have their brain activity monitored using imaging techniques like MRI (Magnetic Resonance Imaging) to assess brain structure and function. Additionally, various scales will be used to evaluate symptoms of depression, anxiety, and other related conditions. The study will also measure biological markers in the blood to understand the role of inflammation in depression. This research hopes to improve understanding of depression and potentially lead to better treatments in the future.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age, gender, and medical history to ensure alignment with the study criteria.

Participants will be grouped based on their current health status: those experiencing a major depressive episode, those in remission, and healthy individuals without a history of neurological or psychiatric disorders.

2 consent and information

Participants will receive detailed information about the study, including its purpose, procedures, and potential risks and benefits.

A written agreement to participate will be required, confirming understanding and willingness to follow the study protocol.

3 baseline measurements

Baseline measurements will be taken, including psychometric scales to assess mental health status. These scales include the Depression Scale (MADRS), Anhedonia Scale (SHAPS), Psychomotor Slowing Scale, Suicide Risk Rating Scale (CSSRS), and BAS Anxiety Rating Scale.

Imaging tests such as MRI will be conducted to gather data on brain structure and function.

4 medication administration

Participants will receive an injection of the tracer 18F-DPA-714 through intravenous administration. This solution is used to visualize brain activity related to inflammation.

The dosage and frequency of administration will be determined by the study protocol and medical team.

5 follow-up assessments

Regular follow-up assessments will be conducted to monitor the participant’s health and response to the tracer. This includes repeated psychometric evaluations and imaging tests.

Biological samples may be collected to measure markers of inflammation and other relevant proteins.

6 final evaluation

At the end of the study period, a final evaluation will be conducted to assess the overall impact of the tracer and gather comprehensive data on brain inflammation patterns.

Participants will receive feedback on their individual results and any relevant findings from the study.

Who Can Join the Study?

Must be male or female and between 18 and 60 years old.
Must provide a written agreement to participate.
Must be able to understand instructions and information.
For the experimental group:
- Must meet the criteria for Major Depressive Disorder (MDD) as defined by the DSM-5, a manual used by healthcare professionals to diagnose mental disorders.
- Must have a MADRS score greater than 20. The MADRS is a scale used to measure the severity of depression symptoms.
- Must be on antidepressant medication that is considered ineffective, with no change in dosage for at least 2 weeks, and have blood levels of the medication checked after one more week without changing the dosage.
For the pathological control group:
- Must have previously met the criteria for MDD as defined by the DSM-5.
- Must be in remission for at least 8 weeks according to the DSM-5.
- Must have a MADRS score less than 10.
- Must be treated with antidepressants with no change in dosage for at least one week.
For the control group:
- Must not have any previous neurological or psychiatric disorders.
- Must have a CRPus level less than 5 mg/L. CRPus is a blood test that measures inflammation in the body.

Who Cannot Join the Study?

Patients who are not diagnosed with Depressive Disorder cannot participate.
Patients who have not been in remission for at least 8 weeks, even if they are still being treated with antidepressants, cannot participate.
Patients who do not match the age and gender criteria of the study groups cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country	Status
Centre Hospitalier Charles Perrens	Bordeaux	France
Cejsbl Hjefxsslhps Rtdbjuvc Usihdkkfrqeko Dz Tjuah	Tours	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	07.12.2018

Trial locations

Antidepressants are medications used to treat major depressive disorder (MDD) and other mood disorders. They work by balancing chemicals in the brain that affect mood and emotions. In this clinical trial, patients who have experienced a major depressive episode and are in remission for at least 8 weeks continue to be treated with antidepressants. These medications help maintain their mental health stability and prevent the recurrence of depressive symptoms.

Depressive disorder – Depressive disorder, also known as major depressive disorder (MDD), is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect a person’s thoughts, behavior, and overall well-being. The progression of depressive disorder can vary, with symptoms ranging from mild to severe. Individuals may experience changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. Emotional symptoms can include feelings of worthlessness or excessive guilt. The disorder can occur in episodes, with periods of remission in between, but it can also be chronic and long-lasting.

Trial ID:

2024-518405-18-00

Protocol code:

RC31/16/8918

NCT ID:

NCT03314155

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Brain Inflammation in Patients with Major Depressive Disorder Using 18F-DPA-714

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