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

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Appendix 12
Study Intervention Participants Outcomes
Core symptoms
ADHD Rating Scale IV – Parent Version
(investigator administered and scored): total
score; hyperactivity/impulsivity subscale
scores; inattention subscale score
CPRS-R: ADHD Index; hyperactive
ADHD Rating Scale IV – Parent Version
(parent scored): total T score
Inclusion criteria
1. Boys aged 7–15 years and girls aged 7–9 years
2. No history of bipolar or psychotic disorders, motor tics or a
family history of Tourette syndrome, substance abuse
3. Participants had to have a response to a previous trial of MPH
4. Participants with other concurrent psychiatric diagnoses were
included in the trial
5. No concomitant use of other psychoactive medications
Arm 1
ATX
For CYP 2D6 extensive metabolisers,
ATX was titrated to a max. of
2 mg/kg per day; administered twice
daily (a.m. and late afternoon) [final
mean dose = 1.40 (0.48) mg/kg per
day]. For CYP 2D6 poor
metabolisers, ATX was initiated at
0.2 mg/kg day and titrated to
1.0 mg/kg day [final mean dose =
0.48 (0.29) mg/kg day]
(Individuals administering medication
not reported)
Reference
Kratochvil et al., 2002; 70
Dittmann et al., 2001305 Source
Updated search
Setting
USA/Canada
Co-existent problems
CPRS-R: cognitive
Diagnostic criteria
DSM-IV
Design
Parallel trial
Educational performance
Not reported
Psychological function
Not reported
Number
Total = 228 (male = 211)
Arm 1 = 184
Arm 2 = 44
Depression or anxiety
Not reported
Total withdrawals = 85
Arm 1 = 66
Arm 2 = 19
Quality of life
CGI of Severity of ADHD Symptoms
Age
10.4 years (mean); 2.1 years (SD)
Arm 2
MPH
Doses beginning at 5 mg from one to
three times daily. Total daily dose did
not exceed 60 mg [final mean dose
= 0.85 (0.53) mg/kg/day
(31.3 mg/day)]
(Individuals administering medication
not reported)
Duration
10 weeks
Purpose
This study was designed
to select treatment
responders to enter a
relapse prevention
study and incorporated
a comparison of ATX
and MPH for ADHD
Adverse events
Assessed through open-ended questions and
collection of ECG and laboratory data. 27
adverse events (including weight) plus blood
pressure and heart rate
IQ
Not reported
Co-morbid disorders
ODD: n = 122, major depressive disorder: n = 15; elimination
disorders, primarily enuresis: n = 38
Additional outcomes
Not reported
Diagnostic subtypes
The majority of children met criteria for the combined ADHD
subtype; 139/184 and 34/44
Additional information
Previous medication:
There was a drug washout period before the trial began (length
not stated). Participants were required to have previously
responded to a trial of MPH
Concurrent medication:
No concomitant use of other psychoactive medications was
allowed by participants in the trial