Outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with ADHD

Randomized placebo-controlled trials have reported efficacy of methylphenidate (MPH) for Attention-deficit/hyperactivity disorder (ADHD); however, selection biases due to strict entry criteria may limit the generalizability of the findings. Few ecologically valid studies have investigated effectiven...

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Autores principales:	Kristine Kaalund-Brok, Tine Bodil Houmann, Marie Bang Hebsgaard, Maj-Britt Glenn Lauritsen, Louise Hyldborg Lundstrøm, Helene Grønning, Lise Darling, Susanna Reinert-Petersen, Morten Aagaard Petersen, Jens Richardt Møllegaard Jepsen, Anne Katrine Pagsberg, Kerstin Jessica Plessen, Henrik Berg Rasmussen, Pia Jeppesen, INDICES
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/a18b6895a9af481db2c0e3811f35a663
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spelling	oai:doaj.org-article:a18b6895a9af481db2c0e3811f35a6632021-11-04T06:07:14ZOutcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with ADHD1932-6203https://doaj.org/article/a18b6895a9af481db2c0e3811f35a6632021-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8530346/?tool=EBIhttps://doaj.org/toc/1932-6203Randomized placebo-controlled trials have reported efficacy of methylphenidate (MPH) for Attention-deficit/hyperactivity disorder (ADHD); however, selection biases due to strict entry criteria may limit the generalizability of the findings. Few ecologically valid studies have investigated effectiveness of MPH in representative clinical populations of children. This independently funded study aims to describe treatment responses and their predictors during the first 12 weeks of MPH treatment using repeated measurements of symptoms and adverse reactions (ARs) to treatment in 207 children recently diagnosed with ADHD. The children were consecutively included from the Child and Adolescent Mental Health Centre, Mental Health Services, The Capital Region of Denmark. The children (mean age, 9.6 years [range 7–12], 75.4% males) were titrated with MPH, based on weekly assessments of symptoms (18-item ADHD-rating scale scores, ADHD-RS-C) and ARs. At study-end 187 (90.8%) children reached a mean end-dose of 1.0 mg/kg/day. A normalisation/borderline normalisation on ADHD-RS-C was achieved for 168 (81.2%) children on the Inattention and/or the Hyperactivity-Impulsivity subscale in week 12, and 31 (15.0%) children were nonresponders, which was defined as absence of normalisation/borderline normalisation (n = 19) or discontinuation due to ARs (n = 12), and eight (3.8%) children dropped out from follow-up. Nonresponders were characterised by more severe symptoms of Hyperactivity-Impulsivity and global impairment before the treatment. ARs were few; the most prominent were appetite reduction and weight loss. A decrease in AR-like symptoms during the treatment period questions the validity of currently available standard instruments designed to measure ARs of MPH. This ecologically valid observational study supports prior randomized placebo-controlled trials; 81.2% of the children responded favourably in multiple domains with few harmful effects to carefully titrated MPH. Clinical trial registration: ClinicalTrials.gov with registration number NCT04366609.Kristine Kaalund-BrokTine Bodil HoumannMarie Bang HebsgaardMaj-Britt Glenn LauritsenLouise Hyldborg LundstrømHelene GrønningLise DarlingSusanna Reinert-PetersenMorten Aagaard PetersenJens Richardt Møllegaard JepsenAnne Katrine PagsbergKerstin Jessica PlessenHenrik Berg RasmussenPia JeppesenINDICESPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Kristine Kaalund-Brok Tine Bodil Houmann Marie Bang Hebsgaard Maj-Britt Glenn Lauritsen Louise Hyldborg Lundstrøm Helene Grønning Lise Darling Susanna Reinert-Petersen Morten Aagaard Petersen Jens Richardt Møllegaard Jepsen Anne Katrine Pagsberg Kerstin Jessica Plessen Henrik Berg Rasmussen Pia Jeppesen INDICES Outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with ADHD
description	Randomized placebo-controlled trials have reported efficacy of methylphenidate (MPH) for Attention-deficit/hyperactivity disorder (ADHD); however, selection biases due to strict entry criteria may limit the generalizability of the findings. Few ecologically valid studies have investigated effectiveness of MPH in representative clinical populations of children. This independently funded study aims to describe treatment responses and their predictors during the first 12 weeks of MPH treatment using repeated measurements of symptoms and adverse reactions (ARs) to treatment in 207 children recently diagnosed with ADHD. The children were consecutively included from the Child and Adolescent Mental Health Centre, Mental Health Services, The Capital Region of Denmark. The children (mean age, 9.6 years [range 7–12], 75.4% males) were titrated with MPH, based on weekly assessments of symptoms (18-item ADHD-rating scale scores, ADHD-RS-C) and ARs. At study-end 187 (90.8%) children reached a mean end-dose of 1.0 mg/kg/day. A normalisation/borderline normalisation on ADHD-RS-C was achieved for 168 (81.2%) children on the Inattention and/or the Hyperactivity-Impulsivity subscale in week 12, and 31 (15.0%) children were nonresponders, which was defined as absence of normalisation/borderline normalisation (n = 19) or discontinuation due to ARs (n = 12), and eight (3.8%) children dropped out from follow-up. Nonresponders were characterised by more severe symptoms of Hyperactivity-Impulsivity and global impairment before the treatment. ARs were few; the most prominent were appetite reduction and weight loss. A decrease in AR-like symptoms during the treatment period questions the validity of currently available standard instruments designed to measure ARs of MPH. This ecologically valid observational study supports prior randomized placebo-controlled trials; 81.2% of the children responded favourably in multiple domains with few harmful effects to carefully titrated MPH. Clinical trial registration: ClinicalTrials.gov with registration number NCT04366609.
format	article
author	Kristine Kaalund-Brok Tine Bodil Houmann Marie Bang Hebsgaard Maj-Britt Glenn Lauritsen Louise Hyldborg Lundstrøm Helene Grønning Lise Darling Susanna Reinert-Petersen Morten Aagaard Petersen Jens Richardt Møllegaard Jepsen Anne Katrine Pagsberg Kerstin Jessica Plessen Henrik Berg Rasmussen Pia Jeppesen INDICES
author_facet	Kristine Kaalund-Brok Tine Bodil Houmann Marie Bang Hebsgaard Maj-Britt Glenn Lauritsen Louise Hyldborg Lundstrøm Helene Grønning Lise Darling Susanna Reinert-Petersen Morten Aagaard Petersen Jens Richardt Møllegaard Jepsen Anne Katrine Pagsberg Kerstin Jessica Plessen Henrik Berg Rasmussen Pia Jeppesen INDICES
author_sort	Kristine Kaalund-Brok
title	Outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with ADHD
title_short	Outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with ADHD
title_full	Outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with ADHD
title_fullStr	Outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with ADHD
title_full_unstemmed	Outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with ADHD
title_sort	outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with adhd
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/a18b6895a9af481db2c0e3811f35a663
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Outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with ADHD

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