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

University of Oslo (UIO)

Status and phase

Completed

Phase 2

Conditions

Myalgic Encephalomyelitis

Chronic Fatigue Syndrome

Treatments

Drug: Clonidine

Drug: Lactose capsula

Study type

Interventional

Funder types

Other

Identifiers

NorCAPITAL.02

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

12 to 18 years old

Volunteers

Accepts 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