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Ongoing studies MODIFI-IBD: Modafinil for severe fatigue in patients with inflammatory bowel disease in remission

About this study

The aim of this study is to investigate whether modafinil reduces severe fatigue in people with Crohn’s disease or ulcerative colitis whose bowel disease is inactive. We compare modafinil with a placebo containing no active medicine. We also investigate side effects and effects on quality of life, sleep, mood, daily functioning and motivation

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About this study

For whom

You may be eligible if you:

  • are 18 to 75 years old;
  • have had Crohn's disease, ulcerative colitis or IBD-unclassified for at least 1 year;
  • have had severe fatigue for at least 6 months;
  • have inactive bowel disease and stable IBD medication for at least 3 months;
  • can complete online questionnaires in Dutch.

You cannot take part if you:

  • are pregnant or breastfeeding, or plan pregnancy during the study or within 2 months after the last dose;
  • have significant heart disease, uncontrolled high blood pressure or a heart rhythm disorder;
  • use medicines that cannot be combined with modafinil;
  • have another physical or mental health condition that may explain the fatigue or make participation unsafe;
  • are taking part in another interventional study.

The study team will assess all eligibility criteria during screening. 

Treatment

A total of 60 people will take part. Randomisation determines which of 2 groups you join. Neither you nor the researchers will know which treatment you receive during the study.

Group 1 - modafinil

  • You take modafinil for 8 weeks.
  • You start with 100 mg per day. If the treatment does not help enough and is well tolerated, the dose may be increased step by step to a maximum of 300 mg per day.

Group 2 - placebo

  • You take capsules without active medicine for 8 weeks.
  • The dosing schedule and possible dose increases are the same as in the modafinil group.

Participation lasts 12 weeks in total. You visit the hospital once for screening, including a medical assessment, physical examination, blood tests, an ECG and, when needed, a stool test. During treatment, the study team contacts you approximately every 2 weeks. You complete questionnaires at 4 time points and perform 2 online tasks about motivation.

Participating hospitals

The study is conducted at:

  • Radboud university medical center, Nijmegen
  • Rijnstate Hospital, Arnhem
  • Maastricht University Medical Center+, Maastricht
  • Amsterdam UMC, Amsterdam

Referral information