| Autor: |
Childress AC; Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada., Kollins SH; Department of Psychiatry and Behavioral Sciences, Duke University, Durham, North Carolina., Foehl HC; Foehl Statistics & Analytics LLC, Glenmoore, Pennsylvania., Newcorn JH; Icahn School of Medicine at Mount Sinai, New York, New York., Mattingly G; Washington University School of Medicine, Midwest Research Group, St. Louis, Missouri., Kupper RJ; Rhodes Pharmaceuticals L.P., Coventry, Rhode Island., Adjei AL; Rhodes Pharmaceuticals L.P., Coventry, Rhode Island. |
| Jazyk: |
angličtina |
| Zdroj: |
Journal of child and adolescent psychopharmacology [J Child Adolesc Psychopharmacol] 2020 Mar; Vol. 30 (2), pp. 58-68. Date of Electronic Publication: 2019 Dec 03. |
| DOI: |
10.1089/cap.2019.0085 |
| Abstrakt: |
Objectives: To assess the efficacy and safety of a methylphenidate hydrochloride extended-release capsule (MPH-MLR) formulation in treating attention-deficit/hyperactivity disorder (ADHD) in preschool children. Methods: Children aged 4 to <6 years with qualifying ADHD Rating Scale Fourth Edition (ADHD-RS-IV) Preschool Version scores (≥90th percentile for age/gender) participated in four behavior management training (BMT) sessions or immediately entered (based on investigator assessment of symptom severity or previous participation) into a 6-week, open-label, flexible MPH-MLR dose optimization phase. After BMT, children with <30% improvement in ADHD-RS-IV score and ≥3 score on the Clinical Global Impression-Improvement (CGI-I) scale also entered the open-label period. All children began the open-label period with MPH-MLR 10 mg once daily; weekly adjustments permitted once-daily maximum of up to 40 mg. Children with ≥30% improvement in ADHD-RS-IV total score and a CGI-I score of 1-2 at open-label completion were randomized to their optimized dose of MPH-MLR or placebo for 2 weeks (double blind [DB]). Safety measures included adverse events (AEs), vital signs, and electrocardiograms. Results: Open-label enrollment was 119 children. Mean (SD) ADHD-RS-IV total scores at open-label start and open-label end was 40.8 (10.4) and 19.5 (11.1), respectively. Ninety children were enrolled in the DB phase. Mean (SD) ADHD-RS-IV total scores for the MPH-MLR and placebo group were similar at DB beginning and was 25.8 (14.6) and 34.9 (14.1), respectively, at DB end. Mean change from baseline in ADHD-RS-IV total score during DB was significantly greater in children randomized to placebo compared with MPH-MLR; least squares mean change difference from baseline was -11.2, p = 0.002. During open-label dosing, the most common AEs (≥10%) were decreased appetite, decreased weight, insomnia, hypertension, emotional disorder, and affect lability. Conclusion: Results demonstrate MPH-MLR efficacy in preschool children and a safety profile consistent with known AEs of methylphenidate when used for ADHD. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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