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

Study Intervention Participants Outcomes
Core symptoms
Not reported
Reference
Greenhill et al., 2002 59
Co-existent problems
Not reported
Source
Updated search
Educational performance
Not reported
Arm 1
MPH
(Metadate CD): mean dose at week 3 was
40.7 mg/day (1.28 mg/kg/day); once daily (a.m.)
(range from 20 to 60 mg)
(Administered by parent)
Setting
USA
Psychological function
Not reported
Inclusion criteria
1. 6–16 years of age
2. No co-morbid psychiatric diagnosis; history of
seizure or tic disorder or a family history of
Tourette’s syndrome
3. IQ > 80
4. Children had to understand study instruction
5. No females who had undergone menarche
6. No use of amphetamines, PEM or an
investigational drug within 30 days of study entry;
concomitant use of clonidine, anticonvulsant drugs
or medications known to affect blood pressure,
heart rate or CNS function
7. No hyperthyroidism or glaucoma or any
concurrent chronic or acute illness
8. No prior non-reponse to a trial of stimulants for
ADHD
9. No previous requirement for a third daily dose in
the afternoon or evening
10. No documented allergy or intolerance to MPH
11. Not currently living with anyone with a substance
abuse disorder
Arm 2
Placebo
(Administered by parent)
Design
Parallel trial
Depression or anxiety
Not reported
Quality of life
Conners’ Global Index: teacher; parent
CGI-ratings
Adverse events
Teacher and Parent Side-Effect Questionnaires
Additional outcomes
Not reported
Duration
3 weeks
Purpose
To compare the efficacy,
safety and tolerability of
once-daily
administration of
modified-release MPH
with placebo in children
with ADHD
© Queen’s Printer and Controller of HMSO 2006. All rights reserved.
Health Technology Assessment 2006; Vol. 10: No. 23
Diagnostic criteria
DSM-IV
Number
Total randomised = 321 (male = 257?)
Arm 1 = 158
Arm 2 = 163
Total withdrawals = 45
Arm 1 = 17
Arm 2 = 28
314 children were included in the ITT efficacy
population (MPH: n = 155, placebo; n = 159)
Age
9 years (mean); 5–15 years (range)
IQ
Not reported
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