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

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Brief Title

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

Official Title

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Mean steps/day count during one week

Secondary Outcome

 Fatigue scores

Condition

Chronic Fatigue Syndrome

Intervention

Clonidine

Study Arms / Comparison Groups

 Clonidine capsula
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

120

Start Date

February 2010

Completion Date

November 2012

Primary Completion Date

June 2012

Eligibility 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
      

Gender

All

Ages

12 Years - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Vegard Bruun Wyller, MD, PhD, , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT01040429

Organization ID

NorCAPITAL.02


Responsible Party

Principal Investigator

Study Sponsor

Oslo University Hospital


Study Sponsor

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


Verification Date

November 2012