orCAPITALThe Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial - NorCAPITA

Conditions: Chronic fatigue syndrom/myalgic encephalomyelitis (CFS/ME) in adolescents

Registration Number: EUCTR2009-016924-30-NO

Lead Sponsor: Division of Paediatrics, Rikshospitalet University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
- Age = 12 years and < 18 years
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Another disease process or current demanding life event that might explain the fatigue
- Another chronic disease
- Permanent use of pharmaceuticals (including hormone drugs)
- Permanently bed-ridden
- Positive pregnancy test
- 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Whether treatment with clonidine increase activity level as compared to placebo in adolescents with CFS/ME;Secondary Objective: - Whether treatment with clonidine improves symptom scores, school attendance, quality of life, autonomic responses and endocrine responses (secondary end points) as compared to placebo in adolescents with CFS/ME<br>- Whether treatment with clonidine improves cognitive functions (executive control functions and emotional memory in particular) and alters functional neuroradiological findings as compared to placebo in adolescents with CFS/ME<br>- Whether eventual differences among the treatment group and the placebo group persist after discontinuation of the drug;Primary end point(s): Mean steps/day count during one week 8 weeks after inclusion

Secondary Outcome Measures