search
Back to results

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

Primary Purpose

Chronic Fatigue Syndrome, Myalgic Encephalomyelitis

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Clonidine
Lactose capsula
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Adolescent, Clonidine, Autonomic nervous system, Stress

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dept. of Pediatrics, Oslo University Hospital Rikshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Clonidine capsula

Lactose capsula

Arm Description

Outcomes

Primary Outcome Measures

Mean steps/day count during one week

Secondary Outcome Measures

Fatigue scores
Pain scores
Algometer testing response
Autonomic symptom scores
Quality of life-score
Disability scores
School attendance
Mean steps/day count during one week
Scores on cognitive function tests
The change in mean arterial pressure (MAP) during head-up tilt-test
The change in heart rate during head-up tilt-test
The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test
Hormonal levels (inluding tryptophan metabolites)
Microbiological analyses

Full Information

First Posted
December 28, 2009
Last Updated
November 19, 2012
Sponsor
Oslo University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01040429
Brief Title
The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Acronym
NorCAPITAL
Official Title
The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Keywords
Adolescent, Clonidine, Autonomic nervous system, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clonidine capsula
Arm Type
Active Comparator
Arm Title
Lactose capsula
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lactose capsula
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean steps/day count during one week
Time Frame
8 weeks after inclusion
Secondary Outcome Measure Information:
Title
Fatigue scores
Time Frame
8 and 30 weeks after inclusion
Title
Pain scores
Time Frame
8 and 30 weeks after inclusion
Title
Algometer testing response
Time Frame
8 and 30 weeks after inclusion
Title
Autonomic symptom scores
Time Frame
8 and 30 weeks after inclusion
Title
Quality of life-score
Time Frame
8 and 30 weeks after inclusion
Title
Disability scores
Time Frame
8 and 30 weeks after inclusion
Title
School attendance
Time Frame
8 and 30 weeks after inclusion
Title
Mean steps/day count during one week
Time Frame
30 weeks after inclusion
Title
Scores on cognitive function tests
Time Frame
8 and 30 weeks after inclusion
Title
The change in mean arterial pressure (MAP) during head-up tilt-test
Time Frame
8 and 30 weeks after inclusion
Title
The change in heart rate during head-up tilt-test
Time Frame
8 and 30 weeks after inclusion
Title
The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test
Time Frame
8 and 30 weeks after inclusion
Title
Hormonal levels (inluding tryptophan metabolites)
Time Frame
8 and 30 weeks after inclusion
Title
Microbiological analyses
Time Frame
8 and 30 weeks after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard Bruun Wyller, MD, PhD
Organizational Affiliation
Dept. of Pediatrics, Oslo University Hospital, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Pediatrics, Oslo University Hospital Rikshospitalet
City
Oslo
ZIP/Postal Code
PO box 4950 Nydalen, 0424 Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
19236717
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.
Results Reference
background
PubMed Identifier
17398200
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.
Results Reference
background
PubMed Identifier
33516248
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.
Results Reference
derived
PubMed Identifier
29202780
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.
Results Reference
derived
PubMed Identifier
28494812
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.
Results Reference
derived
PubMed Identifier
27149955
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. Erratum In: J Transl Med. 2017 Jul 18;15(1):157.
Results Reference
derived
PubMed Identifier
26357864
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.
Results Reference
derived
PubMed Identifier
25287104
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.
Results Reference
derived
PubMed Identifier
24493300
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.
Results Reference
derived
PubMed Identifier
22871021
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs