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

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Appendix 12
Study Intervention Participants Outcomes
Core symptoms
IOWA Conners’ Rating Scale:
inattention/overactivity subscale
(teacher, parent)
SNAP-IV: inattention,
hyperactivity/impulsivity (parent,
teacher)
Arm 1
Placebo
Administered three times daily
(7.30 a.m., 11.30 a.m., 3.30 p.m.)
(Individual administering medication
not reported)
References
Wolraich et al., 2001 97 ;
Wolraich, 2000 325 ;
Wolraich et al., 2002 326
Source
Updated search
Co-existent problems
IOWA Conners’ Rating Scale:
oppositional subscale (teacher,
parent)
SNAP-IV: oppositional, peer
interaction (parent, teacher)
Inclusion criteria
1. Clinical diagnosis of ADHD (any subtype)
2. Aged 6–12 years
3. Patients who were taking MPH or had taken it in the past had to
have been on a total daily MPH dose of at least 10 mg but not more
than 60 mg (immediate or sustained release)
4. No acute or serious chronic disease
5. No hypersensitivity to MPH or previous significant adverse
experiences from MPH
6. No medication that would interfere with safe administration of MPH
7. No glaucoma, Tourette’s syndrome, ongoing seizure disorder or
psychotic disorder
8. No girls who had reached menarche
9. Consent to take study drug as only medication during 4-week trial
Arm 2
MPH
Participants were assigned to a dose
level according to dose titration or
pre-existing dose requirement for
MPH: 15, 30, 45 mg/day given in 3
capsules (7.30 a.m., 11.30 a.m.,
3.30 p.m.); mean daily dose:
0.9 ± 0.4 mg/kg/day
(Individual administering medication
not reported)
Setting
USA
Design
Parallel trial
Duration
Treatment period:
4 weeks
Educational performance
Not reported
Psychological function
Not reported
Diagnostic criteria
Confirmed by Diagnostic Interview Schedule for Children (version 4).
Severity of ADHD symptoms rated both at school and at home using
SNAP-IV, IOWA-C and C-GAS
Depression or anxiety
Not reported
Quality of life
Clinical Global Impression:
improvement (investigators)
Global efficacy (parent, teacher)
Number
Total randomised = 312 (male = 233/282)
Arm 1 = 99
Arm 2 = 107
Arm 3 = 106
Arm 3
MPH
Participants were assigned to a dose
level according to dose titration or
pre-existing dose requirement for
MPH: 18, 36, 54 mg/day in one
extended-release capsule (7.30 a.m.)
plus placebo (11.30 a.m., 3.30 p.m.);
1.1 ± 0.5 mg/kg/day
(Individual administering medication
not reported)
Purpose
To compare the efficacy
and safety of once-a-day
investigational OROS
extended-release MPH
(Concerta) with
conventional MPH
three times a day (MPH
t.d.s.) and placebo in
children with ADHD
Adverse events
Solicited and spontaneous reports:
focus on sleep quality, tics and
appetite (parent)
Additional outcomes
Blood pressure
Pulse rate
Parent Satisfaction Questionnaire
Total withdrawals = 106
Arm 1 = 53
Arm 2 = 26
Arm 3 = 27
Reasons for withdrawals:
Site excluded: n = 30
Never received medication: n = 5
Adverse effects: n = 3; Arm 1: n = 1; Arm 2: n = 1, Arm 3: n = 1
Noncompliance: n = 3; Arm 1: n = 1; Arm 2: n = 1; Arm 3: n = 1
Lost to follow-up: n = 1; Arm 1: n = 0; Arm 2: n = 0; Arm 3: n = 1
Lack of efficacy: n = 59; Arm 1: n = 38; Arm 2: n = 10; Arm 3: n = 11
Could not swallow pills: n = 1; Arm 1: n = 0; Arm 2: n = 0;
Arm 3: n = 1
Protocol violation: n = 2; Arm 1: n = 1; Arm 2: n = 1; Arm 3: n = 0
Did not return: n = 1; Arm 1: n = 1; Arm 2: n = 0; Arm 3: n = 0
continued