Universität zu Köln

Doepfner, Manfred, Ose, Claudia, Fischer, Roland, Ammer, Richard and Scherag, Andre ORCID: 0000-0002-9406-4704 (2011). Comparison of the Efficacy of Two Different Modified Release Methylphenidate Preparations for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in a Natural Setting: Comparison of the Efficacy of Medikinet (R) Retard and Concerta (R)-a Randomized, Controlled, Double-Blind Multicenter Clinical Crossover Trial. J. Child Adolesc. Psychopharmacol., 21 (5). S. 445 - 455. NEW ROCHELLE: MARY ANN LIEBERT, INC. ISSN 1557-8992

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Abstract

Objective: The comparison of the efficacy of Medikinet (R) retard and Concerta (R) trial was a multisite, randomized, double-blind, crossover trial that aimed at comparing the effects of two different modified release methylphenidate preparations (Medikinet retard: 50% immediate release (IR); Concerta: 22% IR) in a natural setting across the day in 113 randomized children and adolescents with attention-deficit/hyperactivity disorder (age range 6-16 years). The duration of the study per patient was 3 weeks. Methods: The primary outcome variable was the German version of the Swanson, Kotkin, Agler, M-Flynn, and Pelham scale in the first 3 hours of school as assessed by teachers. Results: Medikinet retard with a higher IR component than Concerta (and an equivalent daily dose) was superior to Concerta (p = 0.0009), and Medikinet retard with similar IR components in the morning as Concerta (but a lower daily dose) was noninferior to Concerta with regard to the primary outcome. Further, exploratory analyses on teacher and parent ratings on attention-deficit/hyperactivity disorder and on externalizing symptoms during the day revealed no evidence for the superiority of Concerta over Medikinet retard in an equivalent daily dosage throughout the day. Conclusion: Children and adolescents may be treated with a lower daily dose of Medikinet retard (which has a similar IR component as Concerta) without resulting in a clinically relevant worse effect during school time.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Doepfner, Manfred UNSPECIFIED UNSPECIFIED UNSPECIFIED Ose, Claudia UNSPECIFIED UNSPECIFIED UNSPECIFIED Fischer, Roland UNSPECIFIED UNSPECIFIED UNSPECIFIED Ammer, Richard UNSPECIFIED UNSPECIFIED UNSPECIFIED Scherag, Andre UNSPECIFIED orcid.org/0000-0002-9406-4704 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-487777
DOI:	10.1089/cap.2010.0082
Journal or Publication Title:	J. Child Adolesc. Psychopharmacol.
Volume:	21
Number:	5
Page Range:	S. 445 - 455
Date:	2011
Publisher:	MARY ANN LIEBERT, INC
Place of Publication:	NEW ROCHELLE
ISSN:	1557-8992
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ONCE-A-DAY; OROS METHYLPHENIDATE; LABORATORY SCHOOL; ADHD; PLACEBO; FORMULATIONS; RELIABILITY; MEDICATIONS; VALIDITY; SCALE Multiple languages Pediatrics; Pharmacology & Pharmacy; Psychiatry Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/48777