APPENDICES. A systematic review and economic model of the ...

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Appendix 12
Study Intervention Participants Outcomes
Core symptoms
Peer Assessment for Hyperkinetic Disorders
(FBB/HKS) (teachers)
5-point effectiveness scale (parents,
physicians)
Reference
Dopfner et al., 2003 48
Source
Updated search
Co-existent problems
Not reported
Arm 1
MPH
2 × 5-mg immediate-release
capsules for first 2 days; subsequent
dose began at 20-mg sustainedrelease
capsules (for children of
20–30 kg) and could be increased to
a maximum of 60 mg; children of
heavier weights began at higher
dosages and could be increased to a
maximum of 60 mg (20–30 kg: max.
20 mg; 31–50 kg: max. 40 mg;
>50 kg: max 60 mg); once daily
(a.m.)
(Individual administering medication
not reported)
Setting
Germany
Educational performance
Not reported
Inclusion criteria
1. Boys and girls 6–16 years old
2. Attending school
3. IQ = 85
4. Body weight = 20 kg
5. No strong depressive disorder or anxiety disorder
6. No tic or Tourette’s disorder
7. No familial tic disorder
8. No profound developmental disorder or psychosis
9. No previous seizures and no indication of seizure potential on
EEG
10. No MPH or other psychostimulant treatment in the 3 weeks
preceding trial
11. Sufficient knowledge of German
Design
Parallel trial
Psychological function
Not reported
Duration
Treatment periods:
4 weeks.
Depression or anxiety
Not reported
Quality of life
Not reported
Diagnostic criteria
DSM-IV
Number
Total randomised = 85 (male/female split not reported.)
Arm 1 = 43
Arm 2 = 42
Purpose
To test the efficacy and
safety of MPH during
school-time in children
with ADHD
Adverse events
No specific scale reported
Arm 2
Placebo
No details reported
(Individual administering medication
not reported)
Additional outcomes
EEG
Blood pressure
Heart rate
Biochemical levels
Total withdrawals = 7
Arm 1 = 3
Arm 2 = 4
Reasons for withdrawals:
Arm 1: treatment not effective n = 1, unforeseen circumstances
n =2
Arm 2: treatment not effective n =3
In addition, one patient was not included in the final analysis; it
appears that this was because s/he was receiving treatment for
depression (imipramine)
Randomisation procedure:
Participants were randomised across four strata: age, sex, severity
of disorder and centre
Age
Arm 1: 9.8 years (mean); Arm 2: 9.8 years (mean);
Arm 1: 2.4 (SD); Arm 2: 2.1 (SD)
continued