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

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01040429
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome; Myalgic Encephalomyelitis	Drug: Clonidine; Drug: Lactose capsula	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clonidine capsula	Drug: Clonidine; 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.
Placebo Comparator: Lactose capsula	Drug: Lactose capsula; 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

Outcome Measures

Primary Outcome Measures

1. Mean steps/day count during one week [8 weeks after inclusion]

Secondary Outcome Measures

1. Fatigue scores [8 and 30 weeks after inclusion]

2. Pain scores [8 and 30 weeks after inclusion]

3. Algometer testing response [8 and 30 weeks after inclusion]

4. Autonomic symptom scores [8 and 30 weeks after inclusion]

5. Quality of life-score [8 and 30 weeks after inclusion]

6. Disability scores [8 and 30 weeks after inclusion]

7. School attendance [8 and 30 weeks after inclusion]

8. Mean steps/day count during one week [30 weeks after inclusion]

9. Scores on cognitive function tests [8 and 30 weeks after inclusion]

10. The change in mean arterial pressure (MAP) during head-up tilt-test [8 and 30 weeks after inclusion]

11. The change in heart rate during head-up tilt-test [8 and 30 weeks after inclusion]

12. The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test [8 and 30 weeks after inclusion]

13. Hormonal levels (inluding tryptophan metabolites) [8 and 30 weeks after inclusion]

14. Microbiological analyses [8 and 30 weeks after inclusion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Pediatrics, Oslo University Hospital Rikshospitalet	Oslo		Norway	PO box 4950 Nydalen, 0424 Oslo

Sponsors and Collaborators

• Oslo University Hospital

Investigators

• Principal Investigator: Vegard Bruun Wyller, MD, PhD, Dept. of Pediatrics, Oslo University Hospital, Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

• Wyller VB, Due R, Saul JP, Amlie JP, Thaulow E. Usefulness of an abnormal cardiovascular response during low-grade head-up tilt-test for discriminating adolescents with chronic fatigue from healthy controls. Am J Cardiol. 2007 Apr 1;99(7):997-1001. Epub 2007 Feb 16.
• Wyller VB, Eriksen HR, Malterud K. Can sustained arousal explain the Chronic Fatigue Syndrome? Behav Brain Funct. 2009 Feb 23;5:10. doi: 10.1186/1744-9081-5-10.

• Responsible Party: Vegard Bruun Wyller, Associate professor, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT01040429
• Other Study ID Numbers: NorCAPITAL.02
• First Posted: Dec 29, 2009
• Last Update Posted: Nov 20, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Vegard Bruun Wyller, Associate professor, Oslo University Hospital: Adolescent; Clonidine; Autonomic nervous system; Stress
• Additional relevant MeSH terms: Fatigue Syndrome, Chronic; Encephalomyelitis; Syndrome; Fatigue; Clonidine

Study Results

No Results Posted as of Nov 20, 2012