The effect of ondansetron, a 5-Ht3 receptor antagonist, on fatigue severity and functional impairment in Chronic Fatigue Syndrome patients
| ISRCTN | ISRCTN02536681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02536681 |
| Protocol serial number | NTR209 |
| Sponsor | University Medical Centre Nijmegen (Netherlands) |
| Funder | GlaxoSmithKline (Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 15/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr G K H The
Scientific
Scientific
Department Internal Medicine - 541
Expert Center Chronic Fatigue
University Medical Centre Nijmegen
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 361 8819 |
|---|---|
| g.the@aig.umcn.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled, parallel group, double blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Chronic fatigue syndrome |
| Intervention | 10 weeks ondansetron versus placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ondansetron |
| Primary outcome measure(s) |
1. Fatigue severity: measured with Checklist Individual Strength |
| Key secondary outcome measure(s) |
Physical activity level: measured with actometer |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy 2. Lactating women 3. Participation in CFS-treatment programs 4. Participation in other CFS-research 5. Psychopharmaca |
| Date of first enrolment | 19/06/2002 |
| Date of final enrolment | 01/03/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department Internal Medicine - 541
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No |
