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

November 19, 2012 updated by: Vegard Bruun Wyller, Oslo University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, PO box 4950 Nydalen, 0424 Oslo
        • Dept. of Pediatrics, Oslo University Hospital Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean steps/day count during one week
Time Frame: 8 weeks after inclusion
8 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Fatigue scores
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
Pain scores
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
Algometer testing response
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
Autonomic symptom scores
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
Quality of life-score
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
Disability scores
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
School attendance
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
Mean steps/day count during one week
Time Frame: 30 weeks after inclusion
30 weeks after inclusion
Scores on cognitive function tests
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
The change in mean arterial pressure (MAP) during head-up tilt-test
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
The change in heart rate during head-up tilt-test
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
Hormonal levels (inluding tryptophan metabolites)
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion
Microbiological analyses
Time Frame: 8 and 30 weeks after inclusion
8 and 30 weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

December 28, 2009

First Submitted That Met QC Criteria

December 28, 2009

First Posted (ESTIMATE)

December 29, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 19, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NorCAPITAL.02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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