12-month efficacy and safety of OROS® MPH in children and adolescents with attention-deficit/hyperactivity disorder switched from MPH
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The aim of this study was to evaluate long-term clinical treatment with OROS® methylphenidate (MPH) (Concerta®) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who had been previously treated with immediate release (IR) MPH.
Subjects aged 6–16 years (n=105) who were stable on IR MPH (10–60 mg/day) were switched to 18, 36 or 54mg OROS® MPH once daily for 21 days, depending on prestudy MPH dose. Subjects who benefited from OROS® MPH could continue in a 12-month extension period. ADHD symptoms and treatment response were assessed by parents/caregivers and investigators.
Out of 105 enrolled children, 101 completed the 21-day treatment phase. In all, 89 parents/caregivers (88.1%) wanted their child to continue with the study treatment into the extension phase, and 56 children (63 %) completed the 1-year trial. The parent/caregiver global assessment of satisfaction ranged from 49 to 69% during the extension phase, and 49 to 71% of investigators rated the treatment as adequate. Efficacy and satisfaction were found more commonly in patients in the older age group (10–16 years), those on a higher dose (36 mg or 54 mg) and with the predominantly inattentive ADHD subtype. OROS® MPH was well tolerated.
Children and adolescents can effectively and safely be switched from IR MPH to OROS® MPH with improved symptom control and compliance.
- 12-month efficacy and safety of OROS® MPH in children and adolescents with attention-deficit/hyperactivity disorder switched from MPH
European Child & Adolescent Psychiatry
Volume 14, Issue 6 , pp 305-309
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- 1. Child and Family Mental Health Service, Royal Hospital for Sick Children, 3 Rillbank Terrace, Edinburgh EH9 1LL, UK
- 2. Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters, Hans-Sachs-Strasse 6, 35033, Marburg, Germany
- 3. Janssen-Cilag Europe, Middle-East, Africa, Raiffeisenstraße 8, 41470, Neuss, Germany
- 4. Kinder- und Jugendpsychiatrie der Universität Leipzig, Dritte Etage, Riemannstrasse 32–34, 04107, Leipzig, Germany
- 5. Kinder und Jugendpsychiatrie der Georg-August Universität, Von-Siebold-Strasse 5, 37075, Göttingen, Germany
- 6. Maudsley Hospital, Institute of Psychiatry, De Crespigny Park, London SE5 8AF, UK
- 7. Kinder- und Jugendpsychiatrie Klinik Zentralinstitut für seelische Gesundheit, 122120, 68159, Mannheim, Germany
- 8. Orchard House Sussex Weald and Downs NHS Trust, 9 College Lane, Chichester PO19 4PQ, UK
- 9. Leicestershire and Rutland Healthcare Trust, Bridge Park Plaza, Thurmaston, Leicester LE4 8PQ, UK
- 10. Ashurst Hospital, Department of Psychiatry, Lyndhurst, Southampton SO40 7AR, UK
- 11. The Pear Tree Centre Child and Family Therapy Service, Smallwood House, Church Green West, Redditch, Worcestershire B97 4BD, UK
- 12. Privatpraxis, Frohsinnstrasse 26, 63739, Aschaffenburg, Germany