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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Clonidine

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