Effect of Aptensio XR (Methylphenidate HCl Extended-Release) Capsules on Sleep in Children with Attention-Deficit/Hyperactivity Disorder
| Autor: | Ann C. Childress, Judith A. Owens, Akwete L. Adjei, Sharon B. Wigal, Robert J. Kupper, Margaret D. Weiss, Earl Nordbrock, Greg Mattingly, Wei-Wei Chang, Laurence L. Greenhill |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Time Factors MPH-MLR Adolescent Methylphenidate hcl Capsules Placebo 03 medical and health sciences 0302 clinical medicine Double-Blind Method Surveys and Questionnaires medicine Attention deficit hyperactivity disorder Humans 0501 psychology and cognitive sciences Pharmacology (medical) sleep Psychiatry Child Cross-Over Studies Dose-Response Relationship Drug Methylphenidate 05 social sciences Original Articles medicine.disease Crossover study Psychiatry and Mental health CSHQ ASHQ Attention Deficit Disorder with Hyperactivity Delayed-Action Preparations Pediatrics Perinatology and Child Health extended-release methylphenidate Central Nervous System Stimulants Female Sleep (system call) Analysis of variance Extended release Psychology 030217 neurology & neurosurgery 050104 developmental & child psychology medicine.drug |
| Zdroj: | Journal of Child and Adolescent Psychopharmacology |
| ISSN: | 1557-8992 1044-5463 |
| Popis: | Objective: To evaluate measures of sleep (exploratory endpoints) in two pivotal studies of a multilayer bead extended-release methylphenidate (MPH-MLR) treatment of attention-deficit/hyperactivity disorder in children. Methods: Study 1 evaluated the time course of response to MPH-MLR (n = 26) patients in an analog classroom setting through four phases: screening (≤28 days), open label (OL) dose optimization (4 weeks), double-blind (DB) crossover (2 weeks; placebo vs. optimized dose), and follow-up call. Study 2 was a forced-dose parallel evaluation of MPH-MLR (n = 230) in four phases: screening (≤28 days), DB (1 week; placebo or MPH-MLR 10, 15, 20, or 40 mg/day), OL dose optimization (11 weeks), and follow-up call. Sleep was evaluated by parents using the Children's or Adolescent Sleep Habits Questionnaire (CSHQ or ASHQ) during the DB and OL phases. DB analysis: Study 1 (crossover), analysis of variance; Study 2, analysis of covariance. OL analysis: paired t-test. Results: DB: treatments were significantly different in Study 1 only for CSHQ Sleep Onset Delay (MPH-MLR, 1.90 vs. placebo, 1.34; p = 0.0046, placebo was better), and Study 2 for CSHQ Parasomnias (treatment, p = 0.0295), but no MPH-MLR treatment was different from placebo (pairwise MPH-MLR treatment to placebo, all p ≥ 0.170). OL: CSHQ total and Bedtime Resistance, Sleep Duration, Sleep Anxiety, Night Wakings, Parasomnias, and Sleep-disordered Breathing subscales decreased (improved, Study 1) significant only for CSHQ Night Wakings (p |
| Databáze: | OpenAIRE |
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