Vrije Universiteit Brussel
Jette, Belgium
Not recruiting
Study on How Reboxetine and Methylphenidate Affect Fatigue in Healthy Individuals
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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 understanding how certain chemicals in the brain, known as neurotransmitters, affect feelings of tiredness, also called fatigue. The study will look at how these brain chemicals influence fatigue during exercise. The trial involves the use of three different treatments: Edronax, which contains the active ingredient reboxetine; Rilatine Modified Release, which contains methylphenidate hydrochloride; and a placebo. These treatments are given in the form of tablets or capsules that are taken by mouth.
The purpose of the study is to investigate the role of neurotransmitters in fatigue. Participants will receive one of the treatments and will be monitored for changes in how they feel and perform during exercise. The study will observe any physical, behavioral, and subjective changes that occur as a result of the treatments. This will help researchers understand how these brain chemicals might contribute to feelings of fatigue.
The study is designed for healthy individuals between the ages of 18 and 35 who do not have any underlying health conditions related to fatigue, depression, or burnout. Participants will not be taking any other medications, except for contraceptives if needed. The trial aims to provide insights into how neurotransmitters affect fatigue, which could lead to better understanding and management of this common condition.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Age between 18-35 years old
- Healthy male and female individuals
- No use of medications (except contraceptives, which are allowed)
- No indication of risk in general fatigue, depression, and burnout
- Non-smoking
Who cannot join the trial?
1 criterion
- There are no specific exclusion criteria listed for this study.
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Investigated drugs
5-HT
is a short form for serotonin, a chemical in the brain that helps regulate mood, sleep, and other functions. In this trial, researchers are looking at how serotonin affects fatigue during exercise. By understanding its role, they hope to learn more about how the brain gets tired and how to possibly improve energy levels.
DA
stands for dopamine, another important chemical in the brain. Dopamine is involved in how we feel pleasure and motivation. This trial is studying how dopamine might influence feelings of tiredness when we exercise. The goal is to see if changes in dopamine levels can affect how quickly or intensely we feel fatigue.
NA
refers to noradrenaline, a chemical that helps control alertness and the body's response to stress. In this study, researchers are examining how noradrenaline might play a part in exercise-induced fatigue. By exploring its effects, they aim to better understand how the brain manages energy and tiredness during physical activity.
What is already known about the treatment
5-HT, DA, and NA Manipulation – This medication is administered in a form that influences neurotransmitter levels in the brain, specifically targeting serotonin (5-HT), dopamine (DA), and noradrenaline (NA). Currently, it is being studied in clinical trials to understand its effects on exercise-induced fatigue and brain activation, with no established medical conditions for its use yet. The main therapeutic indication is to explore how these neurotransmitters contribute to feelings of tiredness during physical activity. At the molecular level, the medication works by altering the balance of these chemicals in the brain, which can affect mood, energy levels, and overall brain function. It falls under the pharmacological classification of neurotransmitter modulators.
Investigated diseases
Fatigue – Fatigue is a condition characterized by a persistent feeling of tiredness or exhaustion that is not relieved by rest. It can affect physical and mental performance, leading to decreased energy levels and motivation. The progression of fatigue can vary, with symptoms ranging from mild to severe. It may start with a general sense of weariness and can develop into a more profound lack of energy. As it progresses, individuals may experience difficulty concentrating, memory lapses, and reduced physical endurance. Fatigue can be influenced by various factors, including lifestyle, stress, and underlying health conditions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514038-19-00Estimated enrolment59 patientsSponsorVrije Universiteit Brussel
sourced from the EU Clinical Trials Register and site verification
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