Could a wakefulness drug beat fatigue in IBD patients?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Willing and able to provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study * Age between 18 to 75 years at screening. * ≥1 year diagnosis of IBD, based on a combination of clinical, endoscopic, histologic and radiologic criteria * Chronic fatigue for at least six months * Severe fatigue as confirmed with a score of ≥11 on section I of the IBD-F * Clinically quiescent IBD with a Harvey Bradshaw Index (HBI) \<5 for CD patients or a Simple Colitis Clinical Activity Index (SCCAI) ≤2 for patients with UC or IBD-unclassified * Faecal calprotectin \<250 µg/g * Stable IBD medication for ≥3 months before screening visit and no change in IBD medication planned for ≥3 months Exclusion Criteria: * Contraindications for the use of modafinil, such as: * Uncontrolled hypertension * Cardiac arrhythmia * A history of left ventricular hypertrophy or cor pulmonale, and in patients with mitral valve prolapse who have previously developed mitral valve prolapse syn-drome during treatment with central nervous system stimulants * Patients with hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption * Patients using medication which interacts clinically significant with modafinil, see section 3.3 'Mechanism of action \& Drug class' * Patients using pharmacological agents with similar effects to modafinil, like central nerv-ous system (CNS) stimulants or other wakefulness-promoting drugs such as methylphenidate and amphetamines * Surgery before or during study period that impacts ability to participate in this study, per investigator judgement * Participation in another intervention study (excl. registries and post marketing studies) * Pregnancy or nursing at the moment of screening or planned pregnancy within two months after last dose * People with a diagnosis of drug or alcohol dependence syndrome will be excluded * Comorbidities or confirmed diagnoses known to cause fatigue, which may influence study outcomes, including but not limited to: * Anaemia (Hb \<7.0 mmol/l for women and \<8.0 mmol/l for men) and which is judged as clinically significant by the investigator * Folate deficiency (\<6.0 nmol/l) * Iron deficiency (ferritin \<20 g/l for women and \<25 g/L for men) * Vitamin B12 deficiency (\<148 pmol/l) * Liver insufficiency defined by an ALT or AST \>2x ULN or total bilirubin \> 2 mg/dL * Renal insufficiency defined by an estimated glomerular filtration rate \< 45 mL/min, calculated using the Chronic Kidney Disease-Epidemiology Collaboration equation and/or a serum creatinine \>178 μmol/L (2mg/dL) * Auto-immune disorders such as primary sclerosing cholangitis, rheumatoid ar-thritis, systemic lupus erythematosus or coeliac disease * Uncontrolled or recently diagnosed depression * Active suicidal ideation * Bipolar disorder * Schizophrenia or other psychotic disorders * Other psychiatric disorders that may interfere with the study as judged by the investigators * History or current anxiety or sleep disorders * Substance dependence disorders (e.g. alcohol, cannabis, drugs) * Evidence, history, or suspicion of infectious diseases that may interfere with the study as judged by the investigators * Active Epstein-Barr virus or cytomegalovirus infection * Endocrinological disorders such as uncontrolled diabetes mellitus, untreated hy-pothyroidism, hypoadrenalism or hypogonadism * Neurological disorders such as multiple sclerosis, dementia, Parkinson's disease or myasthenia gravis * Heart failure * Chronic obstructive pulmonary disease * Obstructive sleep apnoea * Active malignancy (exception of malignancies adequately treated with resection for non-metastatic basal cell carcinoma) * Long/post-COVID * Patients who are not able to complete the Dutch questionnaires in an online form * Has a clinically significant concurrent disease or relevant laboratory abnormality or a history of illness or medical condition that in the investigator's opinion could confound the study results or increase the participant's risk by taking part in the study