The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial (NorCAPITAL)

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ClinicalTrials.gov Identifier: NCT01040429

Recruitment Status : Completed

First Posted : December 29, 2009

Last Update Posted : November 20, 2012

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Vegard Bruun Wyller, Oslo University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Fatigue Syndrome Myalgic Encephalomyelitis	Drug: Clonidine Drug: Lactose capsula	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Study Start Date :	February 2010
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Fatigue Syndrome Fatigue

Drug Information available for: Clonidine Clonidine hydrochloride

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Clonidine capsula	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.
Placebo Comparator: Lactose capsula	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

Outcome Measures

Primary Outcome Measures :

Mean steps/day count during one week [ Time Frame: 8 weeks after inclusion ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040429

Locations

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Norway
Dept. of Pediatrics, Oslo University Hospital Rikshospitalet
Oslo, Norway, PO box 4950 Nydalen, 0424 Oslo

Sponsors and Collaborators

Oslo University Hospital

Investigators

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Principal Investigator:	Vegard Bruun Wyller, MD, PhD	Dept. of Pediatrics, Oslo University Hospital, Norway

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 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, 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.

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Responsible Party:	Vegard Bruun Wyller, Associate professor, Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT01040429
Other Study ID Numbers:	NorCAPITAL.02
First Posted:	December 29, 2009 Key Record Dates
Last Update Posted:	November 20, 2012
Last Verified:	November 2012

Keywords provided by Vegard Bruun Wyller, Oslo University Hospital:


Adolescent Clonidine Autonomic nervous system Stress

Additional relevant MeSH terms:

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Encephalomyelitis Fatigue Syndrome, Chronic Syndrome Fatigue Disease Pathologic Processes Muscular Diseases Musculoskeletal Diseases Neuroinflammatory Diseases Nervous System Diseases Neuromuscular Diseases Central Nervous System Infections Infections Central Nervous System Diseases	Clonidine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antihypertensive Agents Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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