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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

Hazell 2003.

Methods A 6‐week, double‐blind, randomised, parallel study comparing clonidine vs placebo in methylphenidate‐treated children diagnosed with ADHD
Participants Number of participants screened: not stated
Number of participants included: 29
Number of participants followed up: 25
Number of withdrawals: 4
Diagnosis of ADHD: DSM‐IV (subtype: not stated)
Age: mean 125.4 months (range: 6‐14 years old)
IQ: > 70
Sex: 25 males, 4 females
Methylphenidate‐naïve: none
Ethnicity: white
Country: Australia
Comorbidity: borderline intellectual functioning: 12%, anxiety: 6%, pervasive developmental disorder: 1.5%
Comedication: none
Sociodemographics: not stated
Inclusion criteria
  1. 6 to 14 years

  2. DSM‐IV diagnosis of ADHD and comorbid ODD or CD treated for a minimum of 3 months with either methylphenidate or dexamphetamine

  3. Attended psychiatric or paediatric clinics supervised by the authors

  4. T‐scores for attention problems and aggressive behaviour on the Child Behavior Checklist of ≥ 70, placing them in the 'clinically significant' range


Exclusion criteria
  1. Obsessional symptoms, movement disorders, or psychosis

  2. Mental retardation (IQ < 70)

  3. History as determined by a physician of cardiac anomalies or other medical contraindications to the prescription of clonidine

Interventions Mean methylphenidate dosage: 0.67 mg/kg/day
Administration schedule: not stated
Duration of intervention: 6 weeks
Treatment compliance: not stated
Outcomes Non‐serious adverse events:
Parent and self‐report side effects checklists (Barkley)
Pulse rate, and lying and standing blood pressure. Obtained at baseline and at weekly intervals for 6 weeks
Height and weight assessed at baseline and at week 6
Notes Sample calculation: yes
Any withdrawals due to adverse events: no
Ethics approval: approved by the Hunter Area Health Research Ethics Committee and the University of Newcastle Human Research Ethics Committee
Funding/vested interests: supported by the Australian Rotary Health Research Fund
Authors' affiliations: none declared
Key conclusions of the study authors: the findings support the continued use of clonidine in combination with psychostimulant medication to reduce conduct symptoms associated with attention‐deficit/hyperactivity disorder. Treatment is well tolerated and unwanted effects are transient
Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no. But patients had to have been treated with methylphenidate for a minimum of 3 months