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