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

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Appendix 12
Study Intervention Participants Outcomes
Core symptoms
CPRS: impulsivity/hyperactivity
CTRS: inattentive–passive;
hyperactivity
CPRS: total score
CTRS: total score
Inclusion criteria
1. 6–11 years of age
2. Met at least 8 of the 14 DSM-III-R criteria for ADHD
3. IQ > 50
4. No chronic medical conditions
5. No receipt of ongoing medication (except antiepileptic drug)
6. No substandard height (below –2 SD of the norm)
7. No major psychosocial problems
8. No history of alcohol or drug abuse themselves or of their principal caretaker
Arm 1
Amphetamine sulphate
Dosage was titrated from
5 mg twice daily
(breakfast, lunch) to a
max. of 45 mg/day. Mean
dose 0.52 mg/kg/day
(0.20–1.10).
(Individual administering
medication not reported)
Reference
Gillberg et al., 1997 56
Source
AHRQ Report
Setting
Sweden
Co-existent problems
CPRS: conduct problems
CTRS: conduct problems
Design
Parallel trial
Educational performance
CPRS: inattention/learning problems
CTRS: inattention/learning problems
Diagnostic criteria
DSM-III-R
Number
Total randomised = 62 (male = 51)
Arm 1 = 32
Arm 2 = 30
Arm 2
Placebo
All children received
amphetamine for the first
3 months of the study
(titration phase); at
3 months they were
randomised to DEX or
placebo. Those in the
placebo group had the
active drug withdrawn
gradually over a 2-week
period
(Individual administering
medication not reported)
Duration
Treatment period:
15 months
Psychological function
WISC-R
Depression or anxiety
CTRS: anxious–fearful
Birleson Depression Self-report Scale
McGrath Test
Total withdrawals = 30
Arm 1 = 8
Arm 2 = 22
Purpose
To evaluate the effects
of amphetamine
sulphate on behaviour
and cognition, and
adverse effects during
15 months of treatment
Quality of life
Not reported
Randomisation procedure:
Randomisation was balanced within each site and stratified for age
Adverse events
Incidence of 20 adverse events
Additional outcomes
Height, weight, pulse, blood pressure
Age
9 years (mean); 6–11 years (range); 1.6 (SD)
IQ
51–72 (range)
Co-morbid disorders
Autistic disorder (1); mild mental retardation (10); ODD (8); CD (3); separation
anxiety disorder (2); tics or Tourette syndrome (3). 32/62 had academic problems
or special educational needs
Diagnostic subtypes
Not reported
Additional information
Previous/concurrent medication:
All participants had interventions prior to the study: 2 had amphetamine therapy,
8 had been taking other drugs (neuroleptics, -linolenic–butyric acid and folic acid);
3 were taking carbamazepine and 1 was taking volproic acid throughout study.
Participants were not to receive ongoing medication (except antiepileptic drug)
during the trial