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
Secondary identifying numbers	NTR209

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

Not provided at time of registration

Contact information

Dr G K H The
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
Email	g.the@aig.umcn.nl

Study information

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
Scientific title
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
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

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
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 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

University Medical Centre Nijmegen (Netherlands)
Hospital/treatment centre

P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Phone	+31 (0)24 361 1111
Email	info@ozi.umcn.nl
Website	http://www.umcn.nl/homepage
"ROR"	https://ror.org/05wg1m734

Funders

Funder type

Industry

GlaxoSmithKline (Netherlands)
Government organisation / For-profit companies (industry)

Alternative name(s): GlaxoSmithKline plc., GSK plc., GSK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2010		Yes	No