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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

Verified siteRegistered drugNo placebo
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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 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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

19 criteria

  • 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 trial?

8 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Methylphenidate – Methylphenidate is typically administered orally in the form of tablets or capsules. It is currently well-established in medical literature as a treatment for Attention Deficit Hyperactivity Disorder (ADHD). The main therapeutic use of methylphenidate is to help improve attention, focus, and impulse control in individuals with ADHD. At the molecular level, it works by increasing the levels of certain chemicals in the brain, such as dopamine and norepinephrine, which help improve attention and focus. Methylphenidate is classified as a central nervous system stimulant.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516902-46-00Protocol code7347Estimated enrolment80 patientsSponsorLes Hopitaux Universitaires De Strasbourg

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).