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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis

Intervention / Treatment
-----------------
* Drug: Clonidine
* Drug: Lactose capsula


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clonidine capsula<br> | Drug: Clonidine<br>* 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.<br>|
| Placebo Comparator: Lactose capsula<br> | Drug: Lactose capsula<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean steps/day count during one week |  | 8 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue scores |  | 8 and 30 weeks after inclusion | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent, Clonidine, Autonomic nervous system, Stress