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

Study Intervention Participants Outcomes
Core symptoms
ADHD Rating Scale IV: total score; inattention
symptoms; hyperactivity/impulsive symptoms
CPRS
CTRS
Reference
Michelson et al., 2002; 74
Dunn et al., 2002; 312
Bukstein, 2003313 and
Michelson, 2002 314
Co-existent problems
Not reported
Inclusion criteria
1. 6–16 years of age
2. Had to meet symptom severity threshold
3. No serious medical illness
4. No history of psychosis or bipolar disorder, alcohol or drug
abuse within the past 3 months
5. No ongoing use of psychoactive medications other than the
study drug
Source
Updated search
Educational performance
Not reported
Arm 1
ATX
0.5 mg/kg/day for 3 days, followed by
0.75 mg/kg/day for the remainder of
the first week. The dose was then
increased to 1.0 or 1.5 mg/kg/day;
administered once daily (a.m.)
(Individual administering medication
not reported)
Setting
USA
Psychological function
Not reported
Diagnostic criteria
DSM-IV
Number
Total randomised = 171 (male = 120)
Arm 1 = 85
Arm 2 = 86
Arm 2
Placebo
No details reported
(Individual administering medication
not reported)
Design
Parallel trial
Depression or anxiety
Not reported
Quality of life
CGI severity score
Total withdrawals = 23
Arm 1 = 12
Arm 2 = 11
Adverse events
16 types of adverse effects reported assessed
by open-ended questioning; blood pressure;
pulse; weight; height
One assigned patient did not receive any medication, and
analyses excluded this patient
Duration
6 weeks
Purpose
To assess the efficacy of
one-daily ATX in the
treatment of children
and adolescents with
ADHD
This trial is also
reported in several
abstracts 312–314
© Queen’s Printer and Controller of HMSO 2006. All rights reserved.
Age
10 years (mean); 2 years (SD)
Health Technology Assessment 2006; Vol. 10: No. 23
Additional outcomes
Parent rating of behaviour in evening:
problems with homework/tasks; sitting
through dinner; difficulty playing quietly;
inattentive and distractible; arguing or
struggling; irritability; difficulty with
transitions; difficulty settling at bedtime;
difficulty falling asleep.
Parent rating of behaviour in morning:
difficulty getting out of bed; difficulty getting
ready; arguing or struggling; irritability
IQ
Not reported
Co-morbid disorders
ODD: n = 34; depression: n = 3; generalised anxiety disorder:
n = 1; specific phobia: n = 5
Diagnostic subtypes
ADHD subtype: 58% mixed; 2% hyperactive/impulsive; 41%
inattentive
Additional information
Previous medication:
All patients followed a minimum 5-day medication-free
evaluation period before randomisation. 94 of the children
reported having been previously treated with a stimulant
Concurrent medication:
Participants in the trial were not to receive ongoing psychoactive
medications other than the study drug
303