The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
NCT ID: NCT01040429
Last Updated: 2012-11-20
Study Results
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Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2010-02-28
2012-11-30
Brief Summary
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* 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 Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Clonidine capsula
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.
Lactose capsula
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* Functional disability resulting from fatigue to a degree that prevent normal school attendance
Exclusion Criteria
* 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
12 Years
18 Years
ALL
Yes
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Vegard Bruun Wyller
Associate professor
Principal Investigators
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Vegard Bruun Wyller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Pediatrics, Oslo University Hospital, Norway
Locations
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Dept. of Pediatrics, Oslo University Hospital Rikshospitalet
Oslo, Oslo County, Norway
Countries
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References
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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. doi: 10.1016/j.amjcard.2006.10.067. 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-beta) in adolescent chronic fatigue syndrome. J Transl Med. 2017 Dec 4;15(1):245. doi: 10.1186/s12967-017-1350-1.
Nguyen CB, Alsoe L, Lindvall JM, Sulheim D, Fagermoen E, Winger A, Kaarbo 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.
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, Smastuen 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, Muller F, Rowe PC, Saul JP, Skovlund E, Oie 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.
Other Identifiers
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NorCAPITAL.02
Identifier Type: -
Identifier Source: org_study_id