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The effect of ondansetron, a 5-Ht3 receptor antagonist, on fatigue severity and functional impairment in CFS-patients.


- candidate number0
- NTR NumberNTR209
- ISRCTNISRCTN02536681
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR31-aug-2005
- Secondary IDsN/A 
- Public TitleThe effect of ondansetron, a 5-Ht3 receptor antagonist, on fatigue severity and functional impairment in CFS-patients.
- Scientific TitleThe effect of ondansetron, a 5-Ht3 receptor antagonist, on fatigue severity and functional impairment in CFS-patients.
- ACRONYMN/A
- hypothesisAccumulating data in the literature support an important role for serotonin, in the neurobiology of CFS. Neuroendocrin and neuropharmacological studies point to an up-regulated or hyperresponsive serotonin system.
Positive reports of the use of serotonine inhibitors in the treatment of fatigue, due to hepatitis and to fibromyalgia, support an effect. Based on these findings we hypothesise that a serotonin antagonist could be effective in the treatment of CFS.
- Healt Condition(s) or Problem(s) studiedChronic Fatigue Syndrome (CFS)
- Inclusion criteria1. CDC-diagnosed CFS-patients;
2. Male and female patients 18-65 years of age;
3. High-fatigue severity level;
4. Substantial functional impairment;
5. Written informed consent.
- Exclusion criteria1. Pregancy;
2. Lactating women;
3. Participation in CFS-treatment programs;
4. Participation in other CFS-research;
5. Psychopharmaca.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-jun-2002
- planned closingdate1-mrt-2006
- Target number of participants60
- Interventions10 weeks ondansetron.
- Primary outcome1. Fatigue severity: measured with Checklist Individual Strenght;
2. Functional impairment: measured with Sickness Impact Profile;
. CDC-symptoms.
- Secondary outcomeFysical activity level: measured with actometer.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. G.K.H. The
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.W.M. Meer, van der
- Sponsor/Initiator University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- PublicationsN/A
- Brief summaryAccumulating data in the literature support an important role for serotonin, in the neurobiology of CFS. Neuroendocrin and neuropharmacological studies point to an up-regulated or hyperresponsive serotonin system.
In a RCT by our own research group the SSRI fluoxetine proved to be ineffective in CDC-diagnosed CFS patients.
Positive reports of the use of serotonine inhibitors in the treatment of fatigue, due to hepatitis and to fibromyalgia, support an effect. Based on these findings we hypothesise that a serotonin antagonist could be effective in the treatment of CFS.
- Main changes (audit trail)
- RECORD8-sep-2005 - 6-nov-2008


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