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

Phase 2

Completed

• Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
• Interventions: Drug: Lactose capsula; Drug: Clonidine

• Registration Number: NCT01040429
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-28
• Study First Submitted QC: 2009-12-28
• Study First Posted: 2009-12-29
• Study Start: 2010-02
• Primary Completion: 2012-06
• Status Verified: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-19
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactose capsula	Lactose capsula	-
Clonidine capsula	Clonidine	-

Primary Outcome Measures

Name	Time	Method
Mean steps/day count during one week	8 weeks after inclusion

Secondary Outcome Measures

Name	Time	Method
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
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
Microbiological analyses	8 and 30 weeks after inclusion

Trial Locations

Locations (1)

Dept. of Pediatrics, Oslo University Hospital Rikshospitalet; 🇳🇴 Oslo, Norway