Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
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Paris, France
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Effect of atomoxetine on learning dynamics in healthy adults: a study comparing single dose atomoxetine 40 mg with placebo
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study examines how the noradrenergic system affects learning processes in healthy individuals without any neurological or psychiatric conditions. The research uses atomoxetine, a medication that belongs to a class of drugs called selective noradrenaline reuptake inhibitors, which affect certain chemical messengers in the brain. The study compares the effects of a 40 mg dose of atomoxetine against a placebo to understand how this medication influences learning abilities.
The investigation focuses on measuring how participants perform during learning tasks under different conditions. Participants will complete two types of learning exercises - one with stable conditions and another with changing conditions. During these tasks, various measurements will be taken, including pupil diameter and brain activity through electroencephalography (a method that records electrical activity in the brain). The study involves taking either atomoxetine or a placebo and then completing these learning tasks.
The research will analyze several aspects of learning and brain function, including changes in brain activity patterns, eye movements, and heart function. Additional measurements include hormone levels in saliva and responses to questionnaires about mood and anxiety. This comprehensive approach aims to better understand how the medication affects learning processes in the brain.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Must be between 18 and 39 years old
- Must be right-handed (this will be checked using the Edinburgh handedness scale, which is a simple questionnaire about which hand you use for different activities)
- Must be a healthy person with no history of neurological or psychiatric conditions
- Must be enrolled in the social security system
- Must be able to understand and sign an informed consent form (a document that explains the study details and your rights as a participant)
- Can be either male or female
Who cannot join the trial?
13 criteria
- History of any neurological disorders (conditions affecting the brain, spinal cord, or nerves)
- History of any psychiatric disorders (mental health conditions)
- Age below 18 or above 65 years
- Inability to provide informed consent
- Current use of medications that could interact with atomoxetine (the study medication)
- Known allergies or hypersensitivity to atomoxetine or its components
- Current participation in other clinical trials
- Pregnancy or breastfeeding
- History of substance abuse or dependence
- Significant vision problems that could interfere with performing study tasks
- Inability to complete EEG (brain wave measurement) procedures
- Medical conditions that could affect pupil response measurements
- History of serious adverse reactions to medications similar to atomoxetine
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Investigated drugs
Atomoxetine is a medication that affects how noradrenaline (a natural chemical in the brain) works. It belongs to a group of medications called selective noradrenaline reuptake inhibitors (SNRIs). This medication works by increasing the levels of noradrenaline in the brain, which helps with attention, focus, and learning processes. In this trial, it is being studied to understand how it affects learning abilities and brain activity in healthy people.
What is already known about the treatment
Atomoxetine - A selective norepinephrine reuptake inhibitor administered orally in capsule form, primarily used in the treatment of attention deficit hyperactivity disorder (ADHD). This medication works by increasing the levels of norepinephrine in the brain by blocking its reabsorption into nerve cells, which helps improve attention, focus, and reduce impulsive behavior. Currently well-established in medical practice, atomoxetine belongs to the class of norepinephrine reuptake inhibitors and is being studied for its effects on learning dynamics and cognitive function in healthy individuals, particularly its influence on pupil response and brain activity patterns at a low dose of 40mg.
Investigated diseases
Based on the source data, since the study involves healthy subjects without any diseases and focuses on studying the noradrenergic system's role in learning dynamics, there are no specific diseases to describe. The trial explicitly states it involves "Healthy subjects with no neurological or psychiatric disorders."
However, to provide context for what the study is specifically excluding, I can describe the general categories of conditions that subjects must not have:
Neurological disorders - A broad category of conditions that affect the brain, spinal cord, and nerves throughout the body. These disorders can affect memory, learning, coordination, and other brain functions.
Psychiatric disorders - Mental health conditions that affect mood, thinking, and behavior. These can include conditions that impact cognitive function and learning processes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520959-90-00Protocol codeD24-P017Estimated enrolment176 patientsSponsorGroupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
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