Clinical trial NCT01040429: The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Official title: The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Keywords: Adolescent
Clonidine
Autonomic nervous system
Stress
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2009-12-29
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean steps/day count during one week
timeFrame: 8 weeks after inclusion
Secondary outcomes:
measure: Fatigue scores
timeFrame: 8 and 30 weeks after inclusion
measure: Pain scores
timeFrame: 8 and 30 weeks after inclusion
measure: Algometer testing response
timeFrame: 8 and 30 weeks after inclusion
measure: Autonomic symptom scores
timeFrame: 8 and 30 weeks after inclusion
measure: Quality of life-score
timeFrame: 8 and 30 weeks after inclusion
measure: Disability scores
timeFrame: 8 and 30 weeks after inclusion
measure: School attendance
timeFrame: 8 and 30 weeks after inclusion
measure: Mean steps/day count during one week
timeFrame: 30 weeks after inclusion
measure: Scores on cognitive function tests
timeFrame: 8 and 30 weeks after inclusion
measure: The change in mean arterial pressure (MAP) during head-up tilt-test
timeFrame: 8 and 30 weeks after inclusion
measure: The change in heart rate during head-up tilt-test
timeFrame: 8 and 30 weeks after inclusion
measure: The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test
timeFrame: 8 and 30 weeks after inclusion
measure: Hormonal levels (inluding tryptophan metabolites)
timeFrame: 8 and 30 weeks after inclusion
measure: Microbiological analyses
timeFrame: 8 and 30 weeks after inclusion
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept. of Pediatrics, Oslo University Hospital Rikshospitalet
Study officials:
affiliation: Dept. of Pediatrics, Oslo University Hospital, Norway
name: Vegard Bruun Wyller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.