title: Clonidine in the treatment of adolescent chronic fatigue syndrome: a pilot study for the NorCAPITAL trial.
abstract: BACKGROUND
  This pilot study (ClinicalTrials.gov ID: NCT01507701) assessed the feasibility and safety of clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, we assessed clonidine dosage in relation to a) plasma concentration levels, b) orthostatic cardiovascular responses, and c) possible adverse effects.
  
  
  RESULTS
  Five adolescent CFS patients (14-19 years old) received 50 μg clonidine twice per day during 14 days in an open, uncontrolled design. Plasma concentration of clonidine was assayed by standard laboratory methods. Changes in orthostatic cardiovascular responses were assessed by a 20o head-up tilt-test (HUT). Adverse effects were mapped by a questionnaire.After 14 days, C0 median (range) of clonidine was 0.21 (0.18-0.36) μg/L, and Cmax median (range) of clonidine was 0.41 (0.38-0.56) μg/L. Also, supine blood pressures and heart rate were lower during clonidine treatment, and the HUT response was closer to the normal response. No serious adverse effects were registered.
  
  
  CONCLUSIONS
  Clonidine 50 μg BID seems to be safe enough to proceed from a pilot study to a controlled trial in a select group of adolescents with CFS (ClinicalTrials.gov ID: NCT01040429).
authors.affiliation: Department of Pediatrics, Oslo University Hospital and University of Oslo, Oslo, Norway.
authors.forename: Even
authors.initials: E
authors.lastname: Fagermoen
authors.forename: Dag
authors.initials: D
authors.lastname: Sulheim
authors.forename: Anette
authors.initials: A
authors.lastname: Winger
authors.forename: Anders M
authors.initials: AM
authors.lastname: Andersen
authors.forename: Nils Tore
authors.initials: NT
authors.lastname: Vethe
authors.forename: J Philip
authors.initials: JP
authors.lastname: Saul
authors.forename: Erik
authors.initials: E
authors.lastname: Thaulow
authors.forename: Vegard Bruun
authors.initials: VB
authors.lastname: Wyller
mesh_terms: D000293:Adolescent; D003000:Clonidine / Q000009:adverse effects / Q000627:therapeutic use*; D015673:Fatigue Syndrome, Chronic / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D008297:Male; D009664:Norway; D010865:Pilot Projects; D018667:Tilt-Table Test; D055815:Young Adult
chemical_list: D003000:Clonidine