Condition category
Nervous System Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
15/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic fatigue syndrome

Intervention

10 weeks ondansetron versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Ondansetron

Primary outcome measures

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 trial start date

19/06/2002

Overall trial end date

01/03/2006

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.umcn.nl/homepage

Funders

Funder type

Industry

Funder name

GlaxoSmithKline (Netherlands)

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20122367

Publication citations

  1. Results

    The GK, Bleijenberg G, Buitelaar JK, van der Meer JW, The effect of ondansetron, a 5-HT3 receptor antagonist, in chronic fatigue syndrome: a randomized controlled trial., J Clin Psychiatry, 2010, 71, 5, 528-533, doi: 10.4088/JCP.08m04719whi.

Additional files

Editorial Notes