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

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274 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Not reported Not reported Not reported CPRS: Hyperactivity Index. Mean (SD) at baseline for total group and post-test scores: Placebo: 12.16 (6.78)/8.40 (6.59) Low dose: 12.16 (6.78)/7.91 (7.21) High dose: 12.16 (6.78)/7.13 (6.37) L/H > placebo. p-Values not reported for direct comparisons CTRS: Hyperactivity Index. Mean (SD) at baseline for total group and post-test scores: Placebo: 14.23 (8.31)/13.54 (8.66) Low dose: 14.23 (8.31)/8.48 (7.42) High dose: 14.23 (8.31)/8.20 (6.85) L/H > placebo. p-Values not reported for direct comparisons. Conclusions Authors’ conclusions: The authors drew conclusions regarding the sensitivity of measuring instruments rather than on the effectiveness of MPH Reviewer’s comments: No comments noted
Study Intervention Participants Outcomes Core symptoms CTRS: Hyperactive/Impulsive Children’s Psychiatric Rating Scale: Hyperactivity (recreation therapist rated) CPRS: Hyperactive/Impulsive (for 28 most recently enrolled subjects) Inclusion criteria 1. History of severe hyperactivity, impulsivity and inattention who meet DSM-IV criteria for combined-type ADHD 2. Full-scale IQ >80 on WISC-III 3. No chronic medical or neurological disease including Tourette’s disorder, chronic tic disorder, pervasive developmental disorders and mood or anxiety disorders requiring current treatment Arm 1 Adderall plus non-drug intervention 5–30 mg/kg in two doses, one each week for 2 weeks. Doses based on age, weight, prior medication experience and symptom severity. See additional information (Administered by parent) Reference James et al., 2001 62 Source Updated search Co-existent problems Not reported Educational performance 5-minute timed maths task (arithmetic problems) Setting USA (research school) Design Crossover trial Diagnostic criteria DSM-IV Psychological function Not reported Number Total randomised = 35 (male = 21) Total withdrawals = 0 Arm 2 DEX plus non-drug intervention Extended release; 5–30 mg/kg in two doses, one each week for 2 weeks. Doses based on age, weight, prior medication experience and symptom severity. See additional information (Administered by parent) Depression or anxiety Not reported Duration 8 weeks double-blind followed by 2 weeks open treatment optimisation Quality of life Not reported Age 9.1 years (mean); 6.9–12.2 years (range); 1.5 years (SD) IQ 99.8 (mean) Arm 3 DEX plus non-drug intervention Immediate release; 5–30 mg/kg in two doses, one each week for 2 weeks. Doses based on age, weight, prior medication experience and symptom severity. See additional information (Administered by parent) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Adverse events Stimulant SERS (nurse) Barkley SERS (parent) Purpose To compare the efficacy and time course of single morning doses of Adderall and extendedrelease and immediaterelease dextroamphetamine sulfate Health Technology Assessment 2006; Vol. 10: No. 23 Additional outcomes Weight Co-morbid disorders ODD: n = 10, anxiety disorder: n = 12; enuresis: n = 3; dysthymic disorder: n = 2; and learning disorder: n =6 Arm 4 Placebo plus non-drug intervention See additional information (Administered by parent) Diagnostic subtypes All participants had combined-type ADHD Additional information Previous medication: 15 subjects were naïve to stimulant treatment prior to participation All psychotropic medications were discontinued prior to beginning the study with 3-week medication-free observation period Overall mean low dose was 7.8 mg (range 5–25 mg, 0.24 mg/kg), and the mean high dose was 12.8 mg (range 10–30 mg, 0.39 mg/kg) 275
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366 Appendix 13 Study characteristi
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