ADouble-Blind, Placebo-Controlled Withdrawal Trial of Dexmethylphenidate Hydrochloride in Children with Attention Deficit Hyperactivity Disorder
| Autor: | Scott A. West, Ronald L. Lindsay, Timothy P. Bohan, Jerome B. Zeldis, R. Bart Sangal, Diane E. Johnson, Sharon B. Wigal, Alan J. Levine, C. Keith Conners, L. Eugene Arnold |
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| Rok vydání: | 2004 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Dexmethylphenidate Hydrochloride Placebo Drug Administration Schedule law.invention Double-Blind Method Randomized controlled trial law mental disorders medicine Humans Attention deficit hyperactivity disorder Potency Pharmacology (medical) Child Adverse effect Psychiatry Psychiatric Status Rating Scales Dose-Response Relationship Drug Stereoisomerism medicine.disease Discontinuation Clinical trial Psychiatry and Mental health Treatment Outcome Withholding Treatment Attention Deficit Disorder with Hyperactivity Anesthesia Pediatrics Perinatology and Child Health Methylphenidate Central Nervous System Stimulants Female Psychology |
| Zdroj: | Journal of Child and Adolescent Psychopharmacology. 14:542-554 |
| ISSN: | 1557-8992 1044-5463 |
| Popis: | d,l-threo-methylphenidate HCl (D,L-MPH) is the most common treatment of attention deficit hyperactivity disorder (ADHD). A previous report showed placebo-controlled efficacy for the purified d-isomer (dexmethylphenidate hydrochloride, d-MPH, Focalin) with a 2:1 potency compared to dl, and suggested a 6-hour duration of action. This study complements that report by studying the effect of placebo-controlled discontinuation and retesting the duration of action.A 6-week, open-label titration of d-MPH (2.5-10 mg twice-a-day) was followed by a double-blind, placebo-controlled, 2-week withdrawal study of responders.In the open titration, 82% of the 89 enrolled patients achieved a Clinical Global Impression-Improvement (CGI-I) rating of much or very much improved. Only 5 patients discontinued for adverse events. Seventy-five patients continued into the placebo-controlled discontinuation. For the randomly assigned d-MPH (n=35) and placebo (n=40) groups, mean ages, respectively, were 10.1 +/- 2.9 and 9.9 +/- 2.7 years, 86% and 78% were male, and 70.6% and 80.0% took the ceiling dose of 10 mg twice-daily, respectively. Each group had 80% combined type ADHD and 20% inattentive type. By the end of the 2-week, placebo-masked withdrawal, significantly more placebo patients (24 of 39) than d-MPH continuers (6 of 35) relapsed (61.5% versus 17.1%, p=0.001). Compared to d-MPH continuers, placebo patients deteriorated significantly more in the 2-week period on teacher ratings of the 18 ADHD symptoms rated 0-3 (p=0.028), the 3 p.m. and 6 p.m. parent ADHD symptom ratings (p=0.0026 and p=0.0381, respectively), and clinic (2-3 p.m.) and home (6 p.m.) Math Tests (p=0.024 and p0.0001, respectively). The 6 p.m. scores replicated the significant effect at 6 hours reported in the previous study.d-MPH is safe, tolerable, and effective, with a 6-hour duration of effect suggested by the significant difference from placebo at 6 hours on a double-blind discontinuation. |
| Databáze: | OpenAIRE |
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