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The purpose of this study IS to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine capsula | Active Comparator |
| |
| Lactose capsula | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean steps/day count during one week | 8 weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue scores | 8 and 30 weeks after inclusion | |
| Pain scores | 8 and 30 weeks after inclusion | |
| Algometer testing response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vegard Bruun Wyller, MD, PhD | Dept. of Pediatrics, Oslo University Hospital, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Pediatrics, Oslo University Hospital Rikshospitalet | Oslo | Oslo | PO box 4950 Nydalen, 0424 Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19236717 | Background | 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. | |
| 17398200 | Background | 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. |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Lactose capsula | Drug | 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 |
|
| 8 and 30 weeks after inclusion |
| Autonomic symptom scores | 8 and 30 weeks after inclusion |
| Quality of life-score | 8 and 30 weeks after inclusion |
| Disability scores | 8 and 30 weeks after inclusion |
| School attendance | 8 and 30 weeks after inclusion |
| Mean steps/day count during one week | 30 weeks after inclusion |
| Scores on cognitive function tests | 8 and 30 weeks after inclusion |
| The change in mean arterial pressure (MAP) during head-up tilt-test | 8 and 30 weeks after inclusion |
| The change in heart rate during head-up tilt-test | 8 and 30 weeks after inclusion |
| The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test | 8 and 30 weeks after inclusion |
| Hormonal levels (inluding tryptophan metabolites) | 8 and 30 weeks after inclusion |
| Microbiological analyses | 8 and 30 weeks after inclusion |
| 33516248 | Derived | 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. |
| 29202780 | Derived | 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. |
| 28494812 | Derived | 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. |
| 27149955 | Derived | 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. |
| 26357864 | Derived | 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. |
| 25287104 | Derived | 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. |
| 24493300 | Derived | 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. |
| 22871021 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |