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

Oslo University Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Chronic Fatigue Syndrome Myalgic Encephalomyelitis

Interventions

ClonidineDRUG

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.

Lactose capsulaDRUG

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

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Pediatrics, Oslo University Hospital Rikshospitalet

Oslo, Oslo County, Norway

Outcomes

Primary Outcomes

Mean steps/day count during one week

Time frame: 8 weeks after inclusion