Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Conditions
Keywords
Adolescent, Clonidine, Autonomic nervous system, Stress
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.
Interventions
DRUGClonidine
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.
DRUGLactose 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
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean steps/day count during one week | 8 weeks after inclusion |
Secondary
| Measure | Time frame |
|---|---|
| Pain scores | 8 and 30 weeks after inclusion |
| Algometer testing response | 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 |
| Fatigue scores | 8 and 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 |
| Mean steps/day count during one week | 30 weeks after inclusion |
Countries
Norway
Outcome results
None listed