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

Study Intervention Participants Outcomes
Core symptoms
Attention Deficit/Hyperactivity Disorder
Rating Scale IV–Parent Version: investigator
administered and scored: total,
hyperactivity/impulsivity and inattention
CPRS-Short Form: total, hyperactive
Arm 1
ATX
0.5 mg/kg/day administered in equally
divided doses (morning and late
afternoon)
(Individuals administering medication
not reported)
References
Michelson et al., 2001 73
Newcorn et al., 2004 310
and
Matza et al., 2004 311
Co-existent problems
CRPS-R: Short Form: oppositional
Source
Updated search
Educational performance
Not reported
Inclusion criteria
1. IQ 80 (WISC-III)
2. No serious medical illness, co-morbid psychosis or bipolar
disorder
3. No history of seizure disorder
4. No ongoing use of psychoactive medications other than study
drug
5. No treatment for a co-existing disorder that took precedence
over or otherwise mitigated child’s treatment for ADHD
6. Participants with learning disorders were not excluded
Setting
USA
Psychological function
CPRS-R: cognitive
Arm 2
ATX
0.5 mg/kg/day for first week
0.8 mg/kg/day for second week
1.2 mg/kg/day subsequently
administered in equally divided doses
(morning and late afternoon)
(Individuals administering medication
not reported)
Design
Parallel trial
Depression or anxiety
Children’s Depression Rating Scale – Revised
Diagnostic criteria
DSM-IV
Number
Total randomised = 297 (male = 212)
Arm 1 = 44
Arm 2 = 84
Arm 3 = 85
Arm 4 = 84
Duration
Treatment period:
8 weeks; washout
period: 12–18 days
Quality of life
CGI Severity CHQ (parents): physical,
psychosocial summary score, behaviour, family
activity, parent impact – emotional, parent
impact – time, child emotional, child mental
health, child self-esteem
Purpose
To assess the efficacy of
3 doses of atomoxetine
compared with placebo
in children and
adolescents with ADHD
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Total withdrawals = 49
Arm 1 = 10
Arm 2 = 15
Arm 3 = 12
Arm 4 = 12
Arm 3
ATX
0.5 mg/kg/day for first week
0.8 mg/kg/day for second week
1.2 mg/kg/day for third week
1.8 mg/kg/day subsequently
administered in equally divided doses
(morning and late afternoon)
(Individuals administering medication
not reported)
Health Technology Assessment 2006; Vol. 10: No. 23
Adverse events
Open-ended questioning
Additional outcomes
Blood pressure
Weight
Pulse
Reasons for withdrawals:
Lack of efficacy (n = 10):
Arm 1: n = 3; Arm 2: n = 2; Arm 3: n = 1; Arm 4: n = 4
Lost to follow up: n = 10;
Arm 1: n = 3; Arm 2: n = 1; Arm 3: n = 2; Arm 4: n = 4
Conflict (n = 17):
Arm 1: n = 3; Arm 2: n = 6; Arm 3: n = 4; Arm 4: n = 4
Adverse events (n = 7):
Arm 1: n = 1; Arm 2: n = 2; Arm 3: n = 4; Arm 4: n = 0
Moved: n = 1 (Arm 2)
Physician decision: n = 1 (Arm 2)
Protocol violation: n = 2 (Arm 2)
Entry criteria: n = 1 (Arm 3)
Arm 4
Placebo
Administered morning and late
afternoon
(Individuals administering medication
not reported)
continued
299