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TABLE 14 ER-MPH medium dose (20–40 mg/day) versus placebo<br />

Study Design Intervention – N Age Duration Core outcomes<br />

(years) (weeks)<br />

Administered once daily<br />

Wolraich, 2001 97 P OROS MPH (Concerta) (18, 36 or 6–12 4 Core: SNAP-IV: hyperactivity/impulsivity (parent, teacher)<br />

54 mg/day, o.d.) – 312 QoL: CGI improvement (investigators)<br />

AE: solicited <strong>and</strong> spontaneous reports: focus on sleep<br />

quality, tics <strong>and</strong> appetite (parent)<br />

Greenhill, 2002 59 P MPH-Modified Release (Metadate CD) 5–15 3 Core: not reported<br />

(mean 40.7 mg/day, o.d.) – 321 QoL: CGI (teacher; parent); CGI improvement ratings<br />

AE: Teacher <strong>and</strong> Parent Side-Effect Questionnaires<br />

Quinn, 2003 84 [Confidential information removed]<br />

Dopfner, 200348 P MPH-Retard (Medikinet) (20–60 mg/day, 6–16 4 Core: no hyp; Peer Assessment for Hyperkinetic Disorders<br />

o.d.) – 85 (teachers); <strong>effectiveness</strong> scale (parents, physicians)<br />

QoL: not reported<br />

AE: no specific scale reported<br />

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

Stein, 2003 92 C (4×) OROS MPH (Concerta) (36 mg/day, 5.9–16 4 Core: no hyp; ADHD Rating Scale IV (parents)/ACTeRS<br />

o.d.) – 47 QoL: CGI<br />

AE: SERS (parents)<br />

Swanson, 2004 32 C (3×) OROS MPH (Concerta) (18, 36 or 6–12 3 Core: no hyp; SKAMP: deportment; attention (measured by<br />

54 mg/day, o.d.) – 184 two trained observers)<br />

QoL: not reported<br />

MPH-Modified Release (Metadate CD) AE: side-effects on <strong>the</strong> Barkley Scale<br />

(20, 40 or 60 mg/day, o.d.) –184<br />

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

C, crossover trial (number <strong>of</strong> crossovers); CGI, Clinical Global Improvement; P, parallel trial; SKAMP, Swanson, Kotkin Agler, M-Flynn, Pelham (scale); SNAP, Swanson, Nolan <strong>and</strong><br />

Pelham (scale).<br />

39

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