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

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Appendix 12
Study Intervention Participants Outcomes
Core symptoms
ADHD Rating Scale total score
CPRS-S (short form)
ADHD Rating Scale subscales
(inattentive; hyperactive/impulsive)
Reference
Spencer et al., 2002 89
Source
Updated search
Co-existent problems
Not reported
Inclusion criteria
1. Diagnosis of ADHD
2. Score on ADHD Rating Scale of >1.5 SD above age and gender
norms for their diagnostic subtype (primarily inattentive or primarily
hyperactive/impulsive) or the total score for the combined subtype
3. No poor metabolisers of CYP2D6
4. Weight >2 kg at study entry
5. No documented history of bipolar I or II disorder or any history of
psychosis
6. No history of organic brain disease or history of seizure disorder
7. No psychotropic medication
8. No history of alcohol or drug abuse within past 3 months and on
significant prior or current medical conditions
9. Age 7–13 years
10. Normal intelligence on WISC
Arm 1
ATX
Maximum dose 2 mg/kg/day
(90 mg/day) in two or three daily
doses depending on prior
psychostimulant exposure
(Individual administering medication
not reported)
Setting
USA
Educational performance
Not reported
Design
Parallel trial
Psychological function
Not reported
Arm 2
Placebo
(Individual administering medication
not reported)
Depression or anxiety
Not reported
Quality of life
CGI–ADHD, severity
Diagnostic criteria
DSM-IV
Duration
12 weeks
Purpose
To assess the safety and
efficacy of ATX
compared with placebo
in school-aged children
with ADHD
Adverse events
Unsolicited adverse events
Additional outcomes
Not reported
Number
Total randomised = 144
Arm 1 = 64
Arm 2 = 62
Total withdrawals = 34
Arm 1 = 17
Arm 2 = 17
(For both trials: ATX n = 129, placebo n = 124)
Males: ATX n = 98, placebo n = 103
Females: ATX n = 31, placebo n = 21
Reasons for withdrawals:
The most common reason for discontinuation was lack of efficacy
Randomisation procedure:
Patients were stratified according to prior exposure to psychostimulants.
20 patients with no prior exposure to psychostimulants were
randomised to MPH. MPH treatment was included to validate study
design in the event that ATX failed to separate from placebo. MPH
results not reported
continued