The effect of ondansetron, a 5-Ht3 receptor antagonist, on fatigue severity and functional impairment in CFS-patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23597

Enrollment

Registered

2005-08-31

Start date

2002-06-19

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

10 weeks ondansetron.

Eligibility

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Pregancy; 2. Lactating women; 3. Participation in CFS-treatment programs; 4. Participation in other CFS-research; 5. Psychopharmaca.

Design outcomes

Primary

Measure	Time frame
1. Fatigue severity: measured with Checklist Individual Strenght; 2. Functional impairment: measured with Sickness Impact Profile; . CDC-symptoms.	—

Secondary

Measure	Time frame
Fysical activity level: measured with actometer.	—

Contacts

Public ContactG.K.H. The

University Medical Center St. Radboud, Department Internal Medicine, Expert Center Chronic Fatigue, P.O. Box 9101

g.the@aig.umcn.nl+31 (0)24 3618819

Outcome results