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

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Appendix 12
Study Intervention Participants Outcomes
Core symptoms
PACS: hyperactivity scale
CTRS: hyperactivity
Co-existent problems
PACS: defiance scale
CTRS: defiance scale; conduct problems
References
Zeiner, 1999; 101
Zeiner et al., 1999 98
Source
NICE Report
Educational performance
Not reported
Inclusion criteria
1. Male 7–12-year-olds fulfilling diagnostic criteria for
ADHD
2. IQ of ≥ 70
3. No pervasive developmental disorder, psychosis or
mood disorder
4. No acute or chronic medical or neurological disease
5. Never used stimulants or other psychotropic drug
Arm 1
MPH
Total daily dose of 0.5 mg/kg (8 and
11:30 a.m.) 101
Same dose as on pretrial. Mean daily
dose 22.4 mg (SD 7.4 mg). Range
15–35 mg; administered 2 or 3 times
daily 98
(Individual administering medication
not reported)
Setting
Norway
Psychological function
Children’s Checking Task (CCT)
Continuous Performance Test (CPT)
Paced Auditory Serial-Addition Task (PASAT-A and
PASAR-R)
Maze Coordination Test
Grooved Pegboard Test
Diagnostic criteria
DSM-III-R
Design
Crossover trial
Number
Total randomised = 36 (male = 36/21)
Total withdrawals = 0
Arm 2
Placebo
(Individual administering medication
not reported)
Duration
Two treatment periods
of 3 weeks plus 1-week
washout in between
Two crossover trials were conducted: the second trial 98
only included responders to MPH who subsequently
completed an extended treatment phase (n = 21)
Depression or anxiety
PACS: emotional problems
Age
8.8 years (mean at admission); 1.1 years (SD)
Quality of life
Not reported
IQ
102 (mean)
Adverse events
The authors briefly state that no serious physical sideeffects
were reported
Co-morbid disorders
ODD: n = 23/36; developmental reading disorder:
n = 4/36; delayed development of motor function:
n = 5/36
Purpose
To analyse changes in
behaviour and test
performances during
treatment with MPH
and placebo in ADHD
children and to identify
predictors of clinically
significant responses to
methylphenidate 101
Additional outcomes
Neurodevelopmental examination: total score
Diagnostic subtypes
ADHD Combined Type: >75%. All children in sample
would fulfil ICD-10 for HKD
Additional information
Previous medication:
Participants in the trial were required not to have
previously used stimulants or other psychotropic drugs
To examine changes in
behaviour and test
performances during a
3-week period of
placebo treatment in
ADHD boys who were
receiving extended
MPH treatment 98