Contact information
Type
Scientific
Contact name
Dr G K H The
ORCID ID
Contact details
Department Internal Medicine - 541
Expert Center Chronic Fatigue
University Medical Centre Nijmegen
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 361 8819
g.the@aig.umcn.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
NTR209
Study information
Scientific title
Acronym
Study hypothesis
Accumulating data in the literature support an important role for serotonin, in the neurobiology of Chronic Fatigue Syndrome (CFS). Neuroendocrine and neuropharmacological studies point to an up-regulated or hyper-responsive serotonin system.
In a randomised controlled trial by our own research group the Selective Serotonin Reuptake Inhibitor (SSRI) fluoxetine proved to be ineffective in Centre for Diseases Control (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.
Ethics approval(s)
Ethics approval received from the local medical ethics committee
Study design
Randomised placebo controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Chronic fatigue syndrome
Intervention
10 weeks ondansetron versus placebo.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Ondansetron
Primary outcome measure
1. Fatigue severity: measured with Checklist Individual Strength
2. Functional impairment: measured with Sickness Impact Profile
3. CDC-symptoms
Secondary outcome measures
Physical activity level: measured with actometer
Overall study start date
19/06/2002
Overall study end date
01/03/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
60
Participant exclusion criteria
1. Pregnancy
2. Lactating women
3. Participation in CFS-treatment programs
4. Participation in other CFS-research
5. Psychopharmaca
Recruitment start date
19/06/2002
Recruitment end date
01/03/2006
Locations
Countries of recruitment
Netherlands
Study participating centre
Department Internal Medicine - 541
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
University Medical Centre Nijmegen (Netherlands)
Sponsor details
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 361 1111
info@ozi.umcn.nl
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Industry
Funder name
GlaxoSmithKline (Netherlands)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No |