Characteristics of ADHD Symptom Response/Remission in a Clinical Trial of Methylphenidate Extended Release.

Autor: Weiss M; Child and Adolescent Psychiatry, Cambridge Health Alliance, Cambridge, MA 02138, USA. Margaret.weiss@icloud.com., Childress A; Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV 89128, USA. drann87@aol.com., Nordbrock E; Rhodes Pharmaceuticals L.P., Coventry, RI 02816, USA. earlnordbrock@aol.com., Adjei AL; Rhodes Pharmaceuticals L.P., Coventry, RI 02816, USA. akwete.adjei@rhodespharma.com., Kupper RJ; Rhodes Pharmaceuticals L.P., Coventry, RI 02816, USA. Robert.kupper@rhodestec.com., Mattingly G; Washington University School of Medicine, Washington University, St. Louis, MO 63110, USA. greg@mattingly.com.; Midwest Research Group, St. Charles, MO 63304, USA. greg@mattingly.com.
Jazyk: angličtina
Zdroj: Journal of clinical medicine [J Clin Med] 2019 Apr 05; Vol. 8 (4). Date of Electronic Publication: 2019 Apr 05.
DOI: 10.3390/jcm8040461
Abstrakt: Clinical trials in attention-deficit/hyperactivity disorder (ADHD) have typically measured outcome using clinician ratings on the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) and the Clinical Global Impression-Improvement (CGI-I) scale. Remission has been defined as an endpoint score of less than or equal to 18 on the ADHD-RS-IV (or a mean score of 1). Responders have been defined as patients who achieve a CGI-I score of much or very much improved (1 or 2). There is a lack of agreement in the literature on what percent change in symptoms on the ADHD-RS-IV should be used to define improvement or remission. This study uses data from a clinical trial of a methylphenidate extended release (MPH-MLR; Aptensio XR ® ) phase III clinical trial to attempt to determine the percent change of symptoms that best corresponds with improvement and remission. Symptom remission at endpoint (ADHD-RS-IV total score ≤18) was most closely aligned with a ≥46% reduction in ADHD-RS-IV total score. Clinical improvement was most closely aligned with a ≥40% reduction in ADHD-RS-IV total score. The three different measures of outcome were strongly aligned during double blind and open label treatment, and were independent of subtype status. Our data suggest that at least 40% improvement in symptoms is needed to achieve a robust response at endpoint.
Databáze: MEDLINE
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