Accumulating 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…
ID
Bron
Verkorte titel
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Fatigue severity: measured with Checklist Individual Strenght;
<br>2. Functional impairment: measured with Sickness Impact Profile;
<br>. CDC-symptoms.
Achtergrond van het onderzoek
Accumulating 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.
Doel van het onderzoek
Accumulating 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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
10 weeks ondansetron.
Publiek
Expert Center Chronic Fatigue,
P.O. Box 9101
G.K.H. The
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3618819
g.the@aig.umcn.nl
Wetenschappelijk
Expert Center Chronic Fatigue,
P.O. Box 9101
G.K.H. The
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3618819
g.the@aig.umcn.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregancy;
2. Lactating women;
3. Participation in CFS-treatment programs;
4. Participation in other CFS-research;
5. Psychopharmaca.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL172 |
| NTR-old | NTR209 |
| Ander register | : N/A |
| ISRCTN | ISRCTN02536681 |