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

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Study Intervention Participants Outcomes<br />

Core symptoms<br />

CTRS: hyperactivity<br />

Conners’ Parent Questionnaire (CPQ):<br />

hyperactivity<br />

Reference<br />

Elia et al., 1991; 51<br />

Castellanos et al.,<br />

1996 302<br />

Co-existent problems<br />

Not reported<br />

Arm 1<br />

MPH plus non-drug intervention<br />

Mean dose 0.9 mg/kg/day (week 1),<br />

1.5 mg/kg/day (week 2), 2.5<br />

mg/kg/day (week 3) administered in<br />

two doses (9 a.m., 1 p.m.);<br />

complemented by multidisciplinary<br />

behaviour modification programme<br />

<strong>and</strong> low monoamine diet<br />

(Individual administering medication<br />

not reported)<br />

Source<br />

AHRQ Report<br />

Educational performance<br />

Not reported<br />

Inclusion criteria<br />

1. Fulfils DSM-III criteria for attention deficit disorder with<br />

hyperactivity in at least two settings<br />

2. Score = 2 SDs above age norms on CTRS: Factor IV<br />

(hyperactivity)<br />

3. Full-scale IQ score = 80 on WISC-R<br />

4. No evidence <strong>of</strong> medical or neurological diseases<br />

5. No o<strong>the</strong>r Axis I psychiatric disorder except conduct,<br />

oppostitional, mild overanxious or specific developmental<br />

disorders<br />

Setting<br />

USA<br />

(day hospital)<br />

Psychological function<br />

Visual Continuous Performance Test<br />

Palwin Paired Associate Learning Task<br />

Diagnostic criteria<br />

DSM-III<br />

Design<br />

Crossover trial<br />

Depression or anxiety<br />

Not reported<br />

Number<br />

Total r<strong>and</strong>omised = 48 (male = 48)<br />

No withdrawals reported<br />

Quality <strong>of</strong> life<br />

CGI (physician)<br />

C-GAS<br />

Adverse events<br />

STESS (physician, parents)<br />

Children’s Psychiatric Rating Scale: nervous<br />

mannerism<br />

Arm 2<br />

DEX plus non-drug intervention<br />

Mean dose 0.4 mg/kg/day (week 1),<br />

0.9 mg/kg/day (week 2),<br />

1.3 mg/kg/day (week 3)<br />

administered in two doses (9 a.m.,<br />

1 p.m.); complemented by<br />

multidisciplinary behaviour<br />

modification programme <strong>and</strong> lowmonoamine<br />

diet<br />

(Individual administering medication<br />

not reported)<br />

Duration<br />

Hospital programme:<br />

11 weeks; treatment<br />

period: 9 weeks<br />

(3 weeks per<br />

treatment); baseline<br />

assessment period:<br />

1 week<br />

Purpose<br />

To compare <strong>the</strong> clinical<br />

effects <strong>of</strong> DEX <strong>and</strong><br />

MPH in a sample <strong>of</strong><br />

children with ADHD<br />

© Queen’s Printer <strong>and</strong> Controller <strong>of</strong> HMSO 2006. All rights reserved.<br />

Health Technology Assessment 2006; Vol. 10: No. 23<br />

Additional outcomes<br />

Truncal motor activity<br />

Blood <strong>and</strong> urine samples<br />

Age<br />

8.6 years (mean); 1.7 years (SD); 6–12 years (range)<br />

IQ<br />

105.6 (mean)<br />

Co-morbid disorders<br />

CD: n = 10/48; ODD: n = 12/48; specific developmental<br />

disorders: n = 11; dysthymic disorder: n = 1<br />

Diagnostic subtypes<br />

Not reported<br />

Additional information<br />

Previous medication: 18/48 had received no previous stimulant<br />

treatment. 5/48 had previously taken stimulant treatment. 24/48<br />

were on stimulants at time <strong>of</strong> screening: 20/24 MPH; 2/24 PEM;<br />

2/24 DEX. 1/48 was receiving imipramine at time <strong>of</strong> screening.<br />

(The authors attempted to recruit children who were stimulant<br />

drug non-responders, but this was not successful)<br />

Arm 3<br />

Placebo plus non-drug intervention<br />

Administered twice daily (9 a.m.,<br />

1 p.m.); complemented by<br />

multidisciplinary behaviour<br />

modification programme <strong>and</strong> lowmonoamine<br />

diet<br />

(Individual administering medication<br />

not reported)<br />

Additional information<br />

Where side-effects were severe,<br />

dosages were held at current level,<br />

partially increased or decreased; this<br />

occurred for 19/48 participants<br />

(7 on MPH, 7 on DEX, 5 during<br />

both drug phases)<br />

245

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