Clinical Trial: The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Brief Summary:
The purpose of this study IS to
- explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents, particularly focusing on genetics, infections/immunology, endocrinology, autonomic control and cognitions
- to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity) in adolescent CFS.
Detailed Summary:
Sponsor: Oslo University Hospital
Current Primary Outcome: Mean steps/day count during one week [ Time Frame: 8 weeks after inclusion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Fatigue scores [ Time Frame: 8 and 30 weeks after inclusion ]
- Pain scores [ Time Frame: 8 and 30 weeks after inclusion ]
- Algometer testing response [ Time Frame: 8 and 30 weeks after inclusion ]
- Autonomic symptom scores [ Time Frame: 8 and 30 weeks after inclusion ]
- Quality of life-score [ Time Frame: 8 and 30 weeks after inclusion ]
- Disability scores [ Time Frame: 8 and 30 weeks after inclusion ]
- School attendance [ Time Frame: 8 and 30 weeks after inclusion ]
- Mean steps/day count during one week [ Time Frame: 30 weeks after inclusion ]
- Scores on cognitive function tests [ Time Frame: 8 and 30 weeks after inclusion ]
- The change in mean arterial pressure (MAP) during head-up tilt-test [ Time Frame: 8 and 30 weeks after inclusion ]
- The change in heart rate during head-up tilt-test [ Time Frame: 8 and 30 weeks after inclusion ]
- The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test [ Time Frame: 8 and 30 weeks after inclusion ]
- Hormonal levels (inluding tryptophan metabolites) [ Time Frame: 8 and 30 weeks after inclusion ]
- Microbiological analyses [ Time Frame: 8 and 30 weeks after inclusion ]
Original Secondary Outcome:
- Fatigue scores [ Time Frame: 8 and 30 weeks after inclusion ]
- Pain scores [ Time Frame: 8 and 30 weeks after inclusion ]
- Algometer testing response [ Time Frame: 8 and 30 weeks after inclusion ]
- Autonomic symptom scores [ Time Frame: 8 and 30 weeks after inclusion ]
- Quality of life-score [ Time Frame: 8 and 30 weeks after inclusion ]
- Disability scores [ Time Frame: 8 and 30 weeks after inclusion ]
- School attendance [ Time Frame: 8 and 30 weeks after inclusion ]
- Mean steps/day count during one week [ Time Frame: 30 weeks after inclusion ]
- Scores on cognitive function tests [ Time Frame: 8 and 30 weeks after inclusion ]
- The change in mean arterial pressure (MAP) during head-up tilt-test [ Time Frame: 8 and 30 weeks after inclusion ]
- The change in heart rate during head-up tilt-test [ Time Frame: 8 and 30 weeks after inclusion ]
- The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test [ Time Frame: 8 and 30 weeks after inclusion ]
- Hormonal levels [ Time Frame: 8 and 30 weeks after inclusion ]
- Microbiological analyses [ Time Frame: 8 and 30 weeks after inclusion ]
Information By: Oslo University Hospital
Dates:
Date Received: December 28, 2009
Date Started: February 2010
Date Completion:
Last Updated: November 19, 2012
Last Verified: November 2012