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

Tracking Information
First Submitted Date ICMJE	December 28, 2009
First Posted Date ICMJE	December 29, 2009
Last Update Posted Date	November 20, 2012
Study Start Date ICMJE	February 2010
Actual Primary Completion Date	June 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 28, 2009)	Mean steps/day count during one week [ Time Frame: 8 weeks after inclusion ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01040429 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 18, 2011)	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 Measures ICMJE; (submitted: December 28, 2009)	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 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Official Title ICMJE	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 Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
Intervention ICMJE	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
Study Arms	Active Comparator: Clonidine capsula Intervention: Drug: Clonidine; Placebo Comparator: Lactose capsula Intervention: Drug: Lactose capsula
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. Epub 2007 Feb 16.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 28, 2009)	120
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	November 2012
Actual Primary Completion Date	June 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	12 Years to 18 Years (Child, Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Norway
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01040429
Other Study ID Numbers ICMJE	NorCAPITAL.02
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Vegard Bruun Wyller, Oslo University Hospital
Study Sponsor ICMJE	Oslo University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Vegard Bruun Wyller, MD, PhD Dept. of Pediatrics, Oslo University Hospital, Norway
PRS Account	Oslo University Hospital
Verification Date	November 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP