Study on How Reboxetine and Methylphenidate Affect Fatigue in Healthy Individuals

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What is this study about?

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.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on the criteria: age between 18-35 years, being a healthy individual, non-smoker, and not using medications (except contraceptives).

You will be informed about the study’s purpose, which is to investigate the role of neurotransmitters in fatigue. You will have the opportunity to ask questions and provide your consent to participate.

2 baseline assessment

A baseline assessment will be conducted to record your initial physiological, behavioral, and subjective responses related to fatigue. This will serve as a reference point for future comparisons.

3 medication administration

You will be randomly assigned to receive one of the following: Edronax 4 mg tablets (containing reboxetine), Rilatine Modified Release 10 mg capsules (containing methylphenidate hydrochloride), or a placebo (a tablet with no active medication).

The medication will be taken orally as per the study protocol. The exact dosage, frequency, and duration will be explained to you during this stage.

4 exercise sessions

You will participate in exercise sessions designed to induce fatigue. These sessions will help assess the impact of the medication on your physiological, behavioral, and subjective responses to fatigue.

5 follow-up assessments

Follow-up assessments will be conducted to monitor changes in your responses to fatigue while under the influence of the medication. These assessments will help determine the effects of elevated brain neurotransmitters on fatigue.

6 final visit

At the end of the study, you will attend a final visit. During this visit, the overall findings will be discussed, and any remaining questions you have will be addressed.

Your participation will contribute to understanding the role of brain neurotransmission in fatigue.

Who Can Join the Study?

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 Study?

There are no specific exclusion criteria listed for this study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Vrije Universiteit Brussel	Jette	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.08.2025

Trial locations

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.

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 ID:

2024-514038-19-00

NCT ID:

NCT05880342

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on How Reboxetine and Methylphenidate Affect Fatigue in Healthy Individuals

What is this study about?

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