December 28, 2009
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December 29, 2009
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November 20, 2012
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February 2010
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June 2012 (Final data collection date for primary outcome measure)
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Mean steps/day count during one week [ Time Frame: 8 weeks after inclusion ]
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Same as current
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- 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 ]
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- 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 ]
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Not Provided
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Not Provided
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The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
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The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
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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.
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Not Provided
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Interventional
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Phase 2
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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- Chronic Fatigue Syndrome
- Myalgic Encephalomyelitis
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- Drug: Clonidine
Day 1-56 (week 1-8): 25 microgram (1 capsula) x 2/day for patients < 35 kg; 50 microgram (2 capsula) x 2/day for patients > 35 kg.
Day 57-63 (week 9): 25 microgram (1 capsula) x 1/day for patients < 35 kg; 25 microgram (2 capsula) x 2/day for patients > 35 kg.
- Drug: Lactose capsula
Day 1-56 (week 1-8): 1 capsula x 2/day for patients < 35 kg; 2 capsula x 2/day for patients > 35 kg.
Day 57-63 (week 9): 1 capsula x 1/day for patients < 35 kg; 1 capsula x 2/day for patients > 35 kg
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- Wyller VB, Eriksen HR, Malterud K. Can sustained arousal explain the Chronic Fatigue Syndrome? Behav Brain Funct. 2009 Feb 23;5:10. doi: 10.1186/1744-9081-5-10.
- Wyller VB, Due R, Saul JP, Amlie JP, Thaulow E. Usefulness of an abnormal cardiovascular response during low-grade head-up tilt-test for discriminating adolescents with chronic fatigue from healthy controls. Am J Cardiol. 2007 Apr 1;99(7):997-1001. Epub 2007 Feb 16.
- Asprusten TT, Sletner L, Wyller VBB. Are there subgroups of chronic fatigue syndrome? An exploratory cluster analysis of biological markers. J Transl Med. 2021 Jan 30;19(1):48. doi: 10.1186/s12967-021-02713-9.
- Wyller VB, Nguyen CB, Ludviksen JA, Mollnes TE. Transforming growth factor beta (TGF-β) in adolescent chronic fatigue syndrome. J Transl Med. 2017 Dec 4;15(1):245. doi: 10.1186/s12967-017-1350-1.
- Nguyen CB, Alsøe L, Lindvall JM, Sulheim D, Fagermoen E, Winger A, Kaarbø M, Nilsen H, Wyller VB. Whole blood gene expression in adolescent chronic fatigue syndrome: an exploratory cross-sectional study suggesting altered B cell differentiation and survival. J Transl Med. 2017 May 11;15(1):102. doi: 10.1186/s12967-017-1201-0.
- Wyller VB, Vitelli V, Sulheim D, Fagermoen E, Winger A, Godang K, Bollerslev J. Altered neuroendocrine control and association to clinical symptoms in adolescent chronic fatigue syndrome: a cross-sectional study. J Transl Med. 2016 May 5;14(1):121. doi: 10.1186/s12967-016-0873-1. Erratum in: J Transl Med. 2017 Jul 18;15(1):157.
- Fagermoen E, Sulheim D, Winger A, Andersen AM, Gjerstad J, Godang K, Rowe PC, Saul JP, Skovlund E, Wyller VB. Effects of low-dose clonidine on cardiovascular and autonomic variables in adolescents with chronic fatigue: a randomized controlled trial. BMC Pediatr. 2015 Sep 10;15:117. doi: 10.1186/s12887-015-0428-2.
- Winger A, Kvarstein G, Wyller VB, Sulheim D, Fagermoen E, Småstuen MC, Helseth S. Pain and pressure pain thresholds in adolescents with chronic fatigue syndrome and healthy controls: a cross-sectional study. BMJ Open. 2014 Oct 6;4(9):e005920. doi: 10.1136/bmjopen-2014-005920.
- Sulheim D, Fagermoen E, Winger A, Andersen AM, Godang K, Müller F, Rowe PC, Saul JP, Skovlund E, Øie MG, Wyller VB. Disease mechanisms and clonidine treatment in adolescent chronic fatigue syndrome: a combined cross-sectional and randomized clinical trial. JAMA Pediatr. 2014 Apr;168(4):351-60. doi: 10.1001/jamapediatrics.2013.4647.
- Fagermoen E, Sulheim D, Winger A, Andersen AM, Vethe NT, Saul JP, Thaulow E, Wyller VB. Clonidine in the treatment of adolescent chronic fatigue syndrome: a pilot study for the NorCAPITAL trial. BMC Res Notes. 2012 Aug 7;5:418. doi: 10.1186/1756-0500-5-418.
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Completed
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120
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Same as current
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November 2012
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June 2012 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- Persisting or constantly relapsing fatigue lasting 3 months or more.
- Functional disability resulting from fatigue to a degree that prevent normal school attendance
Exclusion Criteria:
- Another disease process or current demanding life event that might explain the fatigue
- Another chronic disease (in particular pheochromocytoma, polyneuropathy, Renal insufficiency)
- Permanent use of pharmaceuticals (including hormone drugs)
- Permanently bed-ridden
- Positive pregnancy test
- Evidence of reduced cerebral and/or peripheral circulation due to vessel disease
- Know hypersensitivity towards clonidine or inert substances (lactose, sakkarose) in capsula
- Abnormal ECG (in particular bradyarrythmias due to sick sinus syndrome or AV-block. Isolated ectopic beats do not lead to exclusion)
- Supine heart rate < 50 beats/min
- Supine systolic blood pressure < 85 mmHg
- Systolic blood pressure fall upon standing > 30 mmHg
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Sexes Eligible for Study: |
All |
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12 Years to 18 Years (Child, Adult)
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Yes
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Contact information is only displayed when the study is recruiting subjects
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Norway
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NCT01040429
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NorCAPITAL.02
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Yes
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Not Provided
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Not Provided
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Vegard Bruun Wyller, Oslo University Hospital
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Vegard Bruun Wyller, MD, PhD, Dept. of Pediatrics, Oslo University Hospital
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Oslo University Hospital
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Same as current
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Not Provided
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Principal Investigator: |
Vegard Bruun Wyller, MD, PhD |
Dept. of Pediatrics, Oslo University Hospital, Norway |
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Oslo University Hospital
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November 2012
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