Study on the Effects of Methylphenidate on Brain Function in Adults with ADHD, with or without Mood Disorders, Compared to Placebo

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What is this study about?

This clinical trial is focused on studying the effects of the medication methylphenidate on brain activity in adults with Attention Deficit Hyperactivity Disorder (ADHD), with or without mood disorders. The study will compare the effects of methylphenidate to a placebo. Methylphenidate is commonly used to help improve attention and focus in individuals with ADHD. The trial aims to understand how this medication affects brain circuits related to cognitive functions, which are mental processes that include thinking, learning, and memory.

Participants in the study will include adults diagnosed with ADHD, both those who have mood disorders and those who do not, as well as a group of healthy individuals without any psychiatric or neurological history. The study will involve using advanced imaging techniques like EEG (electroencephalogram) and MRI (magnetic resonance imaging) to observe changes in brain activity. These techniques help researchers see how the brain responds to tasks and rest periods, and how methylphenidate might alter these responses.

The study will take place over a period of time, during which participants will receive either methylphenidate or a placebo. Researchers will measure various outcomes, such as changes in brain blood flow and cognitive performance, to determine the impact of the medication. The goal is to better understand how methylphenidate affects brain function in people with ADHD and mood disorders, which could lead to improved treatment strategies in the future.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where the objectives and potential risks of the research will be explained. You will be asked to provide informed consent by signing a document that confirms your understanding and agreement to participate.

A medical examination will be conducted to ensure you meet the study’s inclusion criteria. This includes confirming your age, health insurance status, and understanding of the study. If you are a woman of childbearing age, a blood pregnancy test will be required, and you must agree to use effective contraception throughout the study.

2 group assignment

You will be assigned to one of three groups: ADHD patients without mood disorder, patients with attention deficit due to mood disorders, or healthy control subjects. This assignment is based on your medical history and current health status.

3 medication administration

Depending on your group, you may receive either methylphenidate hydrochloride or a placebo. Methylphenidate is a medication commonly used to treat ADHD. The dosage is 10 mg, taken orally in the form of a tablet.

The frequency and duration of the medication administration will be determined by the study protocol and communicated to you during the trial.

4 EEG and MRI assessments

Throughout the study, you will undergo EEG (electroencephalogram) and MRI (magnetic resonance imaging) assessments. These tests are designed to observe the effects of the medication on brain activity and cognitive functions.

You will be asked to perform specific tasks during these assessments to measure attention, memory, and cognitive flexibility.

5 regular follow-ups

Regular follow-up visits will be scheduled to monitor your health and the effects of the medication. These visits will include discussions about any side effects or changes in your condition.

If you are a woman of childbearing age, a urine pregnancy test will be conducted before each MRI to ensure safety.

6 study completion

At the end of the study, a final assessment will be conducted to evaluate the overall impact of the medication on your cognitive functions and brain activity.

You will be informed of the study’s findings and any relevant information regarding your health and treatment.

Who Can Join the Study?

Must be between 18 and 60 years old.
Must have a social health insurance plan or be a beneficiary of such a plan.
Must understand the study’s goals and risks and provide signed consent.
Must be informed of the results of a prior medical examination.
Must have a health pass related to the COVID-19 pandemic, if required by law.
Must agree not to use illegal drugs during the study (tobacco and alcohol are allowed).
If a woman of childbearing age:
- Must have a negative blood pregnancy test before starting the study treatment.
- Must use effective birth control throughout the study.
- Must agree to take a urine pregnancy test before each MRI scan.
For Group A (ADHD patients without mood disorder):
- Must have a diagnosis of ADHD according to DSM-5 criteria, with symptoms present before age 12.
- May or may not be receiving methylphenidate treatment.
For Group B (patients with attention deficit due to mood disorders):
- Must have ADHD symptoms and a diagnosis of recurrent depressive disorder or bipolar disorder.
- Must be currently euthymic (stable mood) with specific depression and mania scores below 6.
- Must be clinically stable for at least 6 weeks before joining the study.
- Must meet adult ADHD criteria with at least 5 symptoms of inattention or hyperactivity/impulsivity.
- Must not have had significant social, academic, or work issues before mood disorders.
- May or may not be receiving treatment for mood disorders, such as mood stabilizers, certain antidepressants, or benzodiazepines at stable doses.
- May or may not be receiving methylphenidate treatment.
For Group C (healthy control subjects):
- Must have no history of psychiatric or neurological issues.

Who Cannot Join the Study?

Patients with any other significant mental health disorders besides ADHD (Attention Deficit Hyperactivity Disorder) or attention deficit post-mood disorder cannot participate.
Individuals with a history of severe heart problems are excluded.
People who have had a recent stroke or other serious brain injury are not eligible.
Participants who are currently using illegal drugs or abusing alcohol cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Anyone who has participated in another clinical trial within the last 30 days is excluded.
Individuals with a known allergy to methylphenidate (a medication often used to treat ADHD) cannot take part.
Patients who are unable to follow the study procedures for any reason are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier De Colmar	Colmar	France
Htogypto Udhnycaexnrhko Swnrdndypz &qrpuwd Hbsclhe do Hikhvnsrldh	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	26.02.2024

Trial locations

Investigated drugs:

Methylphenidate Hydrochloride

Methylphenidate is a medication commonly used to treat attention deficit hyperactivity disorder (ADHD). It works by affecting certain chemicals in the brain that contribute to hyperactivity and impulse control. In this clinical trial, researchers are studying how methylphenidate influences brain activity in adults with ADHD, both with and without mood disorders. The goal is to understand how this medication affects brain circuits related to cognitive functions, which are important for attention and behavior control.

Investigated diseases:

Attention deficit hyperactivity disorder

Attention Deficit Hyperactivity Disorder (ADHD) – ADHD is a neurodevelopmental disorder characterized by patterns of inattention, hyperactivity, and impulsivity that are more severe than typically observed in individuals at a comparable level of development. The disorder often manifests in childhood and can persist into adulthood. Symptoms of inattention may include difficulty sustaining attention, frequent careless mistakes, and forgetfulness in daily activities. Hyperactivity symptoms can involve excessive fidgeting, an inability to remain seated, and talking excessively. Impulsivity may be seen in hasty actions without forethought, interrupting others, and difficulty waiting for one’s turn. The progression of ADHD can vary, with some individuals experiencing a reduction in symptoms over time, while others may continue to face challenges throughout their lives.

Trial ID:

2024-516902-46-00

Protocol code:

7347

NCT ID:

NCT05832489

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Effects of Methylphenidate on Brain Function in Adults with ADHD, with or without Mood Disorders, Compared to Placebo

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?