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278 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Withdrawals: Six ATX-treated participants, and 1 placebo-treated participant discontinued because of adverse events Treatment-emergent adverse events report by ≥ 5% of participants in either group ATX Placebo (n = 131) (n = 63) Decreased appetite 23 (17.6%) 4 (6.3%) PLA > ATX, p = 0.05 Abdominal pain 20 (15.3) 4 (6.3) Nausea 15 (11.5) 5 (7.9) Somnolence 19 (14.5) 1 (1.6) PLA > ATX, p = 0.05 Headache 9 (6.9) 9 (14.3) Fatigue 13 (9.9) 1 (1.6) PLA > ATX, p = 0.05 Dyspepsia 8 (6.1) 1 (1.6) Vomiting 8 (6.1) 1 (1.6) Diarrhoea 2 (1.5) 4 (6.3) Not reported Not reported Clinical Global Impressions- ADHD-Severity (baseline/endpoint/change) ATX (n = 126): 5.0 (0.8)/3.5 (1.3)/–1.6 (1.4) Placebo (n = 60): 5.0 (0.8)/4.3 (1.0)/–0.7 (1.1) (ATX > placebo, p < 0.05), 95% CI for difference from placebo: –1.2 to 5 Conclusions Authors’ conclusions: The authors state that once-daily administration of ATX in the morning provided safe, rapid, continuous symptom relief that lasted into the evening hours and also into the morning hours. ATX treatment was safe and well tolerated Reviewer’s comments: No comments reported Study Intervention Participants Outcomes [Confidential information removed] Reference Kemner et al., 2004 99 Core symptoms Educational performance Quality of life Adverse events [Confidential information removed] Conclusions Authors’ conclusions: [Confidential information removed] Reviewer’s comments: [Confidential information removed]
Study Intervention Participants Outcomes Core symptoms CTRS: overall severity, inattention and hyperactivity Hillside Behaviour Scale: concentration, interest in tasks, impulse control and gross motor activity (teachers, mothers, psychologists, blinded observers) CPRS: impulsivity and hyperactivity Home Hyperactivity Scale (parents) Children’s Psychiatric Rating Scale: fidgetiness, hyperactivity and distractibility Classroom Code: off-task, minor and gross motor activity, out of chair (blinded observers) Overall Severity Index (blinded observers) Inclusion criteria 1. 6 to 12 years 2. Attending elementary school 3. Free of neurological, tic and psychotic disorders plus no CD 4. Verbal IQ or performance IQ of at least 85 on the WISC-R 5. Parental consent 6. No current or past psychostimulant treatment 7. Meeting severity criteria for hyperactivity (1.8–3.0) Hyperactivity factor score on CTRS and parental reports of behavioural problems at home or observation in clinic) Arm 1 MPH Gradual titration to a maximum of 60 mg/day for optimal efficacy provided no significant side-effects occurred; mean dosage (for first 8 weeks) 1.55 mg/kg/day (Individual administering medication not reported) Reference Klein and Abikoff, 1997 65 Source AHRQ report Setting USA Design Parallel trial Co-existent problems CTRS: conduct problems, sociability Hillside Behaviour Scale: frustration tolerance, initiating aggressive behaviour with peers, joining aggressive activities, cooperation, attitude towards work, attention seeking behaviour and popularity (teachers, mothers, psychologists, blinded observers) CPRS: conduct problems, immaturity, psychosomatic, obsessional and antisocial Children’s Psychiatric Rating Scale: angry affect, temper outbursts, negative and pressure of speech Classroom Code: aggression, verbal aggression, interference, non-compliance and solicitation (blinded observers) Diagnostic criteria Other Clinical psychiatric examinations to confirm pervasive ADHD symptoms carried out with child and parent; school history taken into account Arm 2 MPH plus non-drug intervention Gradual titration to a maximum of 60 mg/day for optimal efficacy provided no signficant side-effects occurred; mean dosage (for first 8 weeks) 1.48 mg/kg/day; MPH for 8 weeks then 4 weeks of placebo BT included parent and teacher education, individualised assessment of child, reinforcement via contract. No formal programme weeks 9–12. (Administered by parent, therapist, teacher) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Duration Treatment period:12 weeks Purpose To assess, in hyperactive children: 1. Relative efficacy of behaviour therapy, MPH and their combination 2. Effects of MPH withdrawal after combined treatment 3. Normalisation effects of the combination Health Technology Assessment 2006; Vol. 10: No. 23 Educational performance WRAT: Reading, Arithmetic, Spelling Psychological function MFFT Paired-Associate Test Depression or anxiety CTRS: anxiety CPRS: anxiety Quality of life CGI (teachers, mothers and psychiatrists) Adverse events No specific scale Number Total randomised = 86 (male = 81) Arm 1 = 29 Arm 2 = 29 Arm 3 = 28 Total withdrawals = 3 [The dropouts are not included in the analyses or sample information (i.e. 89 began the trial)] Age 7.8 years (mean); 1.4 years (SD) IQ Not reported Co-morbid disorders ‘Relatively free’ of co-morbid anxiety, depression and CD (see Inclusion criteria) Diagnostic subtypes Not reported Additional information Previous medication: Note that included subjects were required not to have been on stimulant treatment in the past 4 weeks Additional outcomes WISC-R: verbal IQ, performance IQ, full-scale IQ Arm 3 Placebo and non-drug intervention Behavioural intervention incorporated parent and teacher education, individualised assessment of child, reinforcement via contract. No formal programme weeks 9–12. (Administered by parent, therapist, teacher) 279
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366 Appendix 13 Study characteristi
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