The role of the brain in mental and physical fatigue.

Investigating fundamental mechanisms of mental and physical fatigue using neurotransmitter reuptake inhibitors and electroencephalography: a randomized counterbalanced crossover trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002836-30-BE

Enrollment

Registered

2022-12-20

Start date

2023-03-15

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute mental and physical fatigue in healthy participants

Interventions

Trade Name: Cipramil 20 mg tabletten Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Citalopram CAS Number: 59729-33-8 Concentration unit: mg milligram(s) Concentration type: equal Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Healthy trained individuals (No neurological, cardiovascular or musculoskeletal disorders of any kind) • Male or female • 18 to 35 years old • No medication • Non-smoker Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 62 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Injuries of any kind in the past 6 months • Suffering from a chronic health condition (could be neurological, cardiovascular, internal and musculoskeletal) • Participating in any concomitant care or research trials • History of suffering from any mental/psychiatric disorders (Suffering from a higher risk of burn out, indicated by a total score of = 2.59 on the Burn out assessment tool (BAT), Suffering from high general fatigue, indicated by a score of > or = to 57 on the Multidimensional fatigue inventory (MFI), Suffering from depression, indicated by a score of > or = to 16 on the Beck depression inventory-II (BDI-II)) • Use of medication • Use of caffeine and heavy efforts 24 hours prior each trial • Suffering from colour vision deficiencies • Not eating a standardized meal, the morning of each trial

Design outcomes

Primary

Measure	Time frame
Main Objective: The current project aims to improve our understanding of the fundamental mechanism of physical and mental fatigue, and how mental fatigue affects physical fatigue. We aim to determine the role of brain neurotransmission in the onset of fatigue, identify the brain areas involved, and determine how brain activity and neuromuscular efficiency changes during the onset of fatigue.;Secondary Objective: -To experimentally assess the role of a 5-HT, a DA, and a NA reuptake inhibitor in the onset of exercise-induced fatigue -To identify changes in brain activation associated with altered physical fatigue and fatigue perception -To experimentally assess the effect of a 5-HT, NA or DA reuptake inhibitor on mental fatigue, brain activation and the sources of changes in brain activation -To experimentally assess the role of brain neurotransmitters (5-HT, DA, NA) in the interaction between mental and physical fatigue from a neurophysiological perspective. ;Primary end point(s): The trial ends after 4 sessions (three drug trials, one placebo trial);Timepoint(s) of evaluation of this end point: No evaluation needed, the trials will always end after 4 sessions	—

Measure

Time frame

Main Objective: The current project aims to improve our understanding of the fundamental mechanism of physical and mental fatigue, and how mental fatigue affects physical fatigue. We aim to determine the role of brain neurotransmission in the onset of fatigue, identify the brain areas involved, and determine how brain activity and neuromuscular efficiency changes during the onset of fatigue.;Secondary Objective: -To experimentally assess the role of a 5-HT, a DA, and a NA reuptake inhibitor in the onset of exercise-induced fatigue -To identify changes in brain activation associated with altered physical fatigue and fatigue perception -To experimentally assess the effect of a 5-HT, NA or DA reuptake inhibitor on mental fatigue, brain activation and the sources of changes in brain activation -To experimentally assess the role of brain neurotransmitters (5-HT, DA, NA) in the interaction between mental and physical fatigue from a neurophysiological perspective. ;Primary end point(s): The trial ends after 4 sessions (three drug trials, one placebo trial);Timepoint(s) of evaluation of this end point: No evaluation needed, the trials will always end after 4 sessions

—

Secondary

Measure	Time frame
Secondary end point(s): The trial ends after 4 sessions (three drug trials, one placebo trial);Timepoint(s) of evaluation of this end point: No evaluation needed, the trials will always end after 4 sessions	—

Countries

Belgium

Contacts

Public ContactMFYS research group

Vrije Universiteit Brussel

mfys@vub.be003202 629 22 22

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026