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

Study Intervention Participants Outcomes
Core symptoms
CTRS: Hyperactive/Impulsive
Children’s Psychiatric Rating Scale:
Hyperactivity (recreation therapist rated)
CPRS: Hyperactive/Impulsive (for 28 most
recently enrolled subjects)
Inclusion criteria
1. History of severe hyperactivity, impulsivity and
inattention who meet DSM-IV criteria for
combined-type ADHD
2. Full-scale IQ >80 on WISC-III
3. No chronic medical or neurological disease
including Tourette’s disorder, chronic tic disorder,
pervasive developmental disorders and mood or
anxiety disorders requiring current treatment
Arm 1
Adderall plus non-drug intervention
5–30 mg/kg in two doses, one each week for
2 weeks. Doses based on age, weight, prior
medication experience and symptom severity.
See additional information
(Administered by parent)
Reference
James et al., 2001 62
Source
Updated search
Co-existent problems
Not reported
Educational performance
5-minute timed maths task (arithmetic
problems)
Setting
USA
(research school)
Design
Crossover trial
Diagnostic criteria
DSM-IV
Psychological function
Not reported
Number
Total randomised = 35 (male = 21)
Total withdrawals = 0
Arm 2
DEX plus non-drug intervention
Extended release; 5–30 mg/kg in two doses,
one each week for 2 weeks. Doses based on
age, weight, prior medication experience and
symptom severity. See additional information
(Administered by parent)
Depression or anxiety
Not reported
Duration
8 weeks double-blind
followed by 2 weeks
open treatment
optimisation
Quality of life
Not reported
Age
9.1 years (mean); 6.9–12.2 years (range); 1.5 years
(SD)
IQ
99.8 (mean)
Arm 3
DEX plus non-drug intervention
Immediate release; 5–30 mg/kg in two doses,
one each week for 2 weeks. Doses based on
age, weight, prior medication experience and
symptom severity. See additional information
(Administered by parent)
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Adverse events
Stimulant SERS (nurse)
Barkley SERS (parent)
Purpose
To compare the efficacy
and time course of
single morning doses of
Adderall and extendedrelease
and immediaterelease
dextroamphetamine
sulfate
Health Technology Assessment 2006; Vol. 10: No. 23
Additional outcomes
Weight
Co-morbid disorders
ODD: n = 10, anxiety disorder: n = 12; enuresis:
n = 3; dysthymic disorder: n = 2; and learning
disorder: n =6
Arm 4
Placebo plus non-drug intervention
See additional information
(Administered by parent)
Diagnostic subtypes
All participants had combined-type ADHD
Additional information
Previous medication:
15 subjects were naïve to stimulant treatment prior
to participation
All psychotropic medications were discontinued prior
to beginning the study with 3-week medication-free
observation period
Overall mean low dose was 7.8 mg (range
5–25 mg, 0.24 mg/kg), and the mean high dose
was 12.8 mg (range 10–30 mg, 0.39 mg/kg)
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